Regulatory Open Forum

​​Has anyone else been contacted by FDA for one of these?  said wont present a 482 nor  a 483 but might lead to an inspection.   It will be over 15 days - seems like a lot and is definitely more of a burden on a site than a 4 day inspection.   They said it was voluntary but it cant be moved and was 1 week notice.  Deciding whether to agree to it or not - wanted to know if others have experienced this.

------------------------------
Sheryl Brown-Shimer
Director Regulatory Affairs
Clinton MA
United States
------------------------------

I have had a non-voluntary remote GCP investigation of foreign clinical sites. The 482 was issued to me, since the investigation occurred at our offices, rather than the clinical investigator, but a 483 would have been issued to the investigator if violations had been found. I was requested to provide certified copies of trial documents for examination.

My concern would be that if you refuse a voluntary assessment you are more likely to get scheduled for an inspection. FDA investigators generally seem suspicious of "refusals" to allow them to look into your records.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 09-Mar-2021 15:14
From: Sheryl Brown-Shimer
Subject: FDA "voluntary" Remote Regulatory Assessment

​​Has anyone else been contacted by FDA for one of these?  said wont present a 482 nor  a 483 but might lead to an inspection.   It will be over 15 days - seems like a lot and is definitely more of a burden on a site than a 4 day inspection.   They said it was voluntary but it cant be moved and was 1 week notice.  Deciding whether to agree to it or not - wanted to know if others have experienced this.

------------------------------
Sheryl Brown-Shimer
Director Regulatory Affairs
Clinton MA
United States
------------------------------

Hello Sheryl

I have heard of fake FDA inspections- people posing as FDA.  Honestly,  though,  the real FDA isn't doing that many now.

The FDA must present a 482 to inspect.  Your email makes it sound as if they won't. 

I would call the FDA office the inspection is supposed to be run out of, and confirm this is genuine with the Branch Director.   If it is , then as Glen says, do not refuse, but they must present a 482 to start.

Ginger

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 10-Mar-2021 08:08
From: Glen Park
Subject: FDA "voluntary" Remote Regulatory Assessment

I have had a non-voluntary remote GCP investigation of foreign clinical sites. The 482 was issued to me, since the investigation occurred at our offices, rather than the clinical investigator, but a 483 would have been issued to the investigator if violations had been found. I was requested to provide certified copies of trial documents for examination.

My concern would be that if you refuse a voluntary assessment you are more likely to get scheduled for an inspection. FDA investigators generally seem suspicious of "refusals" to allow them to look into your records.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 09-Mar-2021 15:14
From: Sheryl Brown-Shimer
Subject: FDA "voluntary" Remote Regulatory Assessment

​​Has anyone else been contacted by FDA for one of these?  said wont present a 482 nor  a 483 but might lead to an inspection.   It will be over 15 days - seems like a lot and is definitely more of a burden on a site than a 4 day inspection.   They said it was voluntary but it cant be moved and was 1 week notice.  Deciding whether to agree to it or not - wanted to know if others have experienced this.

------------------------------
Sheryl Brown-Shimer
Director Regulatory Affairs
Clinton MA
United States
------------------------------

Ginger - It is my understanding that for remote GMP "investigations" where an FDA investigator is not at a facility they call it an investigation rather than an inspection and do not issue a 482. Findings could trigger an inspection. When the FDA came to our offices to do the remote GCP inspection, the investigator explained that being at the Sponsor's facility allowed them to call it an inspection and issue a 482 because the clinical investigation was performed under our Sponsorship. A bit of double-speak all around, but that is how they justify it.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 11-Mar-2021 07:59
From: Ginger Cantor
Subject: FDA "voluntary" Remote Regulatory Assessment

Hello Sheryl

I have heard of fake FDA inspections- people posing as FDA.  Honestly,  though,  the real FDA isn't doing that many now.

The FDA must present a 482 to inspect.  Your email makes it sound as if they won't.

I would call the FDA office the inspection is supposed to be run out of, and confirm this is genuine with the Branch Director.   If it is , then as Glen says, do not refuse, but they must present a 482 to start.

Ginger

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 10-Mar-2021 08:08
From: Glen Park
Subject: FDA "voluntary" Remote Regulatory Assessment

I have had a non-voluntary remote GCP investigation of foreign clinical sites. The 482 was issued to me, since the investigation occurred at our offices, rather than the clinical investigator, but a 483 would have been issued to the investigator if violations had been found. I was requested to provide certified copies of trial documents for examination.

My concern would be that if you refuse a voluntary assessment you are more likely to get scheduled for an inspection. FDA investigators generally seem suspicious of "refusals" to allow them to look into your records.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 09-Mar-2021 15:14
From: Sheryl Brown-Shimer
Subject: FDA "voluntary" Remote Regulatory Assessment

​​Has anyone else been contacted by FDA for one of these?  said wont present a 482 nor  a 483 but might lead to an inspection.   It will be over 15 days - seems like a lot and is definitely more of a burden on a site than a 4 day inspection.   They said it was voluntary but it cant be moved and was 1 week notice.  Deciding whether to agree to it or not - wanted to know if others have experienced this.

------------------------------
Sheryl Brown-Shimer
Director Regulatory Affairs
Clinton MA
United States
------------------------------

Yeah Glen very interesting.

I would still confirm with the office.  This sounds similar to a competitive fishing expedition.  How are they assured it is FDA ?  Open all your files for 3 weeks..

I am a consultant and clearly have skepticism  but would advise my clients to confirm this truly is FDA first.


Just me.....
Ginger

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 11-Mar-2021 08:23
From: Glen Park
Subject: FDA "voluntary" Remote Regulatory Assessment

Ginger - It is my understanding that for remote GMP "investigations" where an FDA investigator is not at a facility they call it an investigation rather than an inspection and do not issue a 482. Findings could trigger an inspection. When the FDA came to our offices to do the remote GCP inspection, the investigator explained that being at the Sponsor's facility allowed them to call it an inspection and issue a 482 because the clinical investigation was performed under our Sponsorship. A bit of double-speak all around, but that is how they justify it.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 11-Mar-2021 07:59
From: Ginger Cantor
Subject: FDA "voluntary" Remote Regulatory Assessment

Hello Sheryl

I have heard of fake FDA inspections- people posing as FDA.  Honestly,  though,  the real FDA isn't doing that many now.

The FDA must present a 482 to inspect.  Your email makes it sound as if they won't.

I would call the FDA office the inspection is supposed to be run out of, and confirm this is genuine with the Branch Director.   If it is , then as Glen says, do not refuse, but they must present a 482 to start.

Ginger

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 10-Mar-2021 08:08
From: Glen Park
Subject: FDA "voluntary" Remote Regulatory Assessment

I have had a non-voluntary remote GCP investigation of foreign clinical sites. The 482 was issued to me, since the investigation occurred at our offices, rather than the clinical investigator, but a 483 would have been issued to the investigator if violations had been found. I was requested to provide certified copies of trial documents for examination.

My concern would be that if you refuse a voluntary assessment you are more likely to get scheduled for an inspection. FDA investigators generally seem suspicious of "refusals" to allow them to look into your records.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 09-Mar-2021 15:14
From: Sheryl Brown-Shimer
Subject: FDA "voluntary" Remote Regulatory Assessment

​​Has anyone else been contacted by FDA for one of these?  said wont present a 482 nor  a 483 but might lead to an inspection.   It will be over 15 days - seems like a lot and is definitely more of a burden on a site than a 4 day inspection.   They said it was voluntary but it cant be moved and was 1 week notice.  Deciding whether to agree to it or not - wanted to know if others have experienced this.

------------------------------
Sheryl Brown-Shimer
Director Regulatory Affairs
Clinton MA
United States
------------------------------

Absolutely I would require some authentic identification.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 11-Mar-2021 08:31
From: Ginger Cantor
Subject: FDA "voluntary" Remote Regulatory Assessment

Yeah Glen very interesting.

I would still confirm with the office.  This sounds similar to a competitive fishing expedition.  How are they assured it is FDA ?  Open all your files for 3 weeks..

I am a consultant and clearly have skepticism  but would advise my clients to confirm this truly is FDA first.


Just me.....
Ginger

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 11-Mar-2021 08:23
From: Glen Park
Subject: FDA "voluntary" Remote Regulatory Assessment

Ginger - It is my understanding that for remote GMP "investigations" where an FDA investigator is not at a facility they call it an investigation rather than an inspection and do not issue a 482. Findings could trigger an inspection. When the FDA came to our offices to do the remote GCP inspection, the investigator explained that being at the Sponsor's facility allowed them to call it an inspection and issue a 482 because the clinical investigation was performed under our Sponsorship. A bit of double-speak all around, but that is how they justify it.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 11-Mar-2021 07:59
From: Ginger Cantor
Subject: FDA "voluntary" Remote Regulatory Assessment

Hello Sheryl

I have heard of fake FDA inspections- people posing as FDA.  Honestly,  though,  the real FDA isn't doing that many now.

The FDA must present a 482 to inspect.  Your email makes it sound as if they won't.

I would call the FDA office the inspection is supposed to be run out of, and confirm this is genuine with the Branch Director.   If it is , then as Glen says, do not refuse, but they must present a 482 to start.

Ginger

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 10-Mar-2021 08:08
From: Glen Park
Subject: FDA "voluntary" Remote Regulatory Assessment

I have had a non-voluntary remote GCP investigation of foreign clinical sites. The 482 was issued to me, since the investigation occurred at our offices, rather than the clinical investigator, but a 483 would have been issued to the investigator if violations had been found. I was requested to provide certified copies of trial documents for examination.

My concern would be that if you refuse a voluntary assessment you are more likely to get scheduled for an inspection. FDA investigators generally seem suspicious of "refusals" to allow them to look into your records.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 09-Mar-2021 15:14
From: Sheryl Brown-Shimer
Subject: FDA "voluntary" Remote Regulatory Assessment

​​Has anyone else been contacted by FDA for one of these?  said wont present a 482 nor  a 483 but might lead to an inspection.   It will be over 15 days - seems like a lot and is definitely more of a burden on a site than a 4 day inspection.   They said it was voluntary but it cant be moved and was 1 week notice.  Deciding whether to agree to it or not - wanted to know if others have experienced this.

------------------------------
Sheryl Brown-Shimer
Director Regulatory Affairs
Clinton MA
United States
------------------------------

I came across the attached presentation on the topic of Remote Regulatory Assessments (RRAs) and Remote Record Reviews (RRRs).
Also, the only mention I found in recent approval packages is from the nifurtimox approval with an example of how a RRR request was handled/declined and the fact that it resulted in an IR instead (also attached). I'm sure we'll have more examples come up in future approvals.

Hope this helps.
Amin

------------------------------
Amin Osmani
Cofounder/CEO
Toronto ON
Canada
------------------------------

Original Message:
Sent: 11-Mar-2021 08:44
From: Glen Park
Subject: FDA "voluntary" Remote Regulatory Assessment

Absolutely I would require some authentic identification.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 11-Mar-2021 08:31
From: Ginger Cantor
Subject: FDA "voluntary" Remote Regulatory Assessment

Yeah Glen very interesting.

I would still confirm with the office.  This sounds similar to a competitive fishing expedition.  How are they assured it is FDA ?  Open all your files for 3 weeks..

I am a consultant and clearly have skepticism  but would advise my clients to confirm this truly is FDA first.


Just me.....
Ginger

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 11-Mar-2021 08:23
From: Glen Park
Subject: FDA "voluntary" Remote Regulatory Assessment

Ginger - It is my understanding that for remote GMP "investigations" where an FDA investigator is not at a facility they call it an investigation rather than an inspection and do not issue a 482. Findings could trigger an inspection. When the FDA came to our offices to do the remote GCP inspection, the investigator explained that being at the Sponsor's facility allowed them to call it an inspection and issue a 482 because the clinical investigation was performed under our Sponsorship. A bit of double-speak all around, but that is how they justify it.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 11-Mar-2021 07:59
From: Ginger Cantor
Subject: FDA "voluntary" Remote Regulatory Assessment

Hello Sheryl

I have heard of fake FDA inspections- people posing as FDA.  Honestly,  though,  the real FDA isn't doing that many now.

The FDA must present a 482 to inspect.  Your email makes it sound as if they won't.

I would call the FDA office the inspection is supposed to be run out of, and confirm this is genuine with the Branch Director.   If it is , then as Glen says, do not refuse, but they must present a 482 to start.

Ginger

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 10-Mar-2021 08:08
From: Glen Park
Subject: FDA "voluntary" Remote Regulatory Assessment

I have had a non-voluntary remote GCP investigation of foreign clinical sites. The 482 was issued to me, since the investigation occurred at our offices, rather than the clinical investigator, but a 483 would have been issued to the investigator if violations had been found. I was requested to provide certified copies of trial documents for examination.

My concern would be that if you refuse a voluntary assessment you are more likely to get scheduled for an inspection. FDA investigators generally seem suspicious of "refusals" to allow them to look into your records.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States

Original Message:
Sent: 09-Mar-2021 15:14
From: Sheryl Brown-Shimer
Subject: FDA "voluntary" Remote Regulatory Assessment

​​Has anyone else been contacted by FDA for one of these?  said wont present a 482 nor  a 483 but might lead to an inspection.   It will be over 15 days - seems like a lot and is definitely more of a burden on a site than a 4 day inspection.   They said it was voluntary but it cant be moved and was 1 week notice.  Deciding whether to agree to it or not - wanted to know if others have experienced this.

------------------------------
Sheryl Brown-Shimer
Director Regulatory Affairs
Clinton MA
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Hello! We recently received an RRA request. It was from the same FDA auditor that we had in 2018, so we knew if was legitimate.  Attached is the information that we were sent (redacted) regarding the RRA and process.  It was pretty painless and we ended up with no findings - however, the auditor stressed that just because the RRA had no findings, doesn't mean that the FDA will not audit onsite.  The interesting item, was that in order to get a copy of the RRA report, you have to request it from FOIA.
Original Message:
Sent: 09-Mar-2021 15:14
From: Sheryl Brown-Shimer
Subject: FDA "voluntary" Remote Regulatory Assessment

​​Has anyone else been contacted by FDA for one of these?  said wont present a 482 nor  a 483 but might lead to an inspection.   It will be over 15 days - seems like a lot and is definitely more of a burden on a site than a 4 day inspection.   They said it was voluntary but it cant be moved and was 1 week notice.  Deciding whether to agree to it or not - wanted to know if others have experienced this.

------------------------------
Sheryl Brown-Shimer
Director Regulatory Affairs
Clinton MA
United States
------------------------------

Thank you for sharing these documents.

------------------------------
Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
------------------------------

Original Message:
Sent: 22-Mar-2021 20:33
From: Anonymous Member
Subject: FDA "voluntary" Remote Regulatory Assessment

This message was posted by a user wishing to remain anonymous

Hello! We recently received an RRA request. It was from the same FDA auditor that we had in 2018, so we knew if was legitimate.  Attached is the information that we were sent (redacted) regarding the RRA and process.  It was pretty painless and we ended up with no findings - however, the auditor stressed that just because the RRA had no findings, doesn't mean that the FDA will not audit onsite.  The interesting item, was that in order to get a copy of the RRA report, you have to request it from FOIA.
Original Message:
Sent: 09-Mar-2021 15:14
From: Sheryl Brown-Shimer
Subject: FDA "voluntary" Remote Regulatory Assessment

​​Has anyone else been contacted by FDA for one of these?  said wont present a 482 nor  a 483 but might lead to an inspection.   It will be over 15 days - seems like a lot and is definitely more of a burden on a site than a 4 day inspection.   They said it was voluntary but it cant be moved and was 1 week notice.  Deciding whether to agree to it or not - wanted to know if others have experienced this.

------------------------------
Sheryl Brown-Shimer
Director Regulatory Affairs
Clinton MA
United States
------------------------------

How many days and hours per day were required? Was there a lot of back and forth?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 22-Mar-2021 20:33
From: Anonymous Member
Subject: FDA "voluntary" Remote Regulatory Assessment

This message was posted by a user wishing to remain anonymous

Hello! We recently received an RRA request. It was from the same FDA auditor that we had in 2018, so we knew if was legitimate.  Attached is the information that we were sent (redacted) regarding the RRA and process.  It was pretty painless and we ended up with no findings - however, the auditor stressed that just because the RRA had no findings, doesn't mean that the FDA will not audit onsite.  The interesting item, was that in order to get a copy of the RRA report, you have to request it from FOIA.
Original Message:
Sent: 09-Mar-2021 15:14
From: Sheryl Brown-Shimer
Subject: FDA "voluntary" Remote Regulatory Assessment

​​Has anyone else been contacted by FDA for one of these?  said wont present a 482 nor  a 483 but might lead to an inspection.   It will be over 15 days - seems like a lot and is definitely more of a burden on a site than a 4 day inspection.   They said it was voluntary but it cant be moved and was 1 week notice.  Deciding whether to agree to it or not - wanted to know if others have experienced this.

------------------------------
Sheryl Brown-Shimer
Director Regulatory Affairs
Clinton MA
United States
------------------------------

This message was posted by a user wishing to remain anonymous

In our particular case, I would estimate about 4 hours of document compilation and upload into the recommended FDA portal.  There was a 30-minute pre-meeting prior to the audit day as the auditor informed us of the documents they wanted to review. On the day of the RRA, we spent about two hours with the auditor answering their questions on the documents we submitted and a few other questions.  Your experience may be different, as our auditor was familiar with our devices/facility and we did not have a lot of changes from the 2018 audit, so I believe this made the RRA quicker. 

We did submit a FOIA to the FDA for the RRA final report and received it within two-weeks of the request.  Hope this help.
Original Message:
Sent: 29-Jul-2021 15:24
From: Ed Panek
Subject: FDA "voluntary" Remote Regulatory Assessment

How many days and hours per day were required? Was there a lot of back and forth?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 22-Mar-2021 20:33
From: Anonymous Member
Subject: FDA "voluntary" Remote Regulatory Assessment

This message was posted by a user wishing to remain anonymous

Hello! We recently received an RRA request. It was from the same FDA auditor that we had in 2018, so we knew if was legitimate.  Attached is the information that we were sent (redacted) regarding the RRA and process.  It was pretty painless and we ended up with no findings - however, the auditor stressed that just because the RRA had no findings, doesn't mean that the FDA will not audit onsite.  The interesting item, was that in order to get a copy of the RRA report, you have to request it from FOIA.
Original Message:
Sent: 09-Mar-2021 15:14
From: Sheryl Brown-Shimer
Subject: FDA "voluntary" Remote Regulatory Assessment

​​Has anyone else been contacted by FDA for one of these?  said wont present a 482 nor  a 483 but might lead to an inspection.   It will be over 15 days - seems like a lot and is definitely more of a burden on a site than a 4 day inspection.   They said it was voluntary but it cant be moved and was 1 week notice.  Deciding whether to agree to it or not - wanted to know if others have experienced this.

------------------------------
Sheryl Brown-Shimer
Director Regulatory Affairs
Clinton MA
United States
------------------------------

Thanks,

Were you able to respond to the questions verbally or were more documents required?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 30-Jul-2021 20:01
From: Anonymous Member
Subject: FDA "voluntary" Remote Regulatory Assessment

This message was posted by a user wishing to remain anonymous

In our particular case, I would estimate about 4 hours of document compilation and upload into the recommended FDA portal.  There was a 30-minute pre-meeting prior to the audit day as the auditor informed us of the documents they wanted to review. On the day of the RRA, we spent about two hours with the auditor answering their questions on the documents we submitted and a few other questions.  Your experience may be different, as our auditor was familiar with our devices/facility and we did not have a lot of changes from the 2018 audit, so I believe this made the RRA quicker.

We did submit a FOIA to the FDA for the RRA final report and received it within two-weeks of the request.  Hope this help.
Original Message:
Sent: 29-Jul-2021 15:24
From: Ed Panek
Subject: FDA "voluntary" Remote Regulatory Assessment

How many days and hours per day were required? Was there a lot of back and forth?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 22-Mar-2021 20:33
From: Anonymous Member
Subject: FDA "voluntary" Remote Regulatory Assessment

This message was posted by a user wishing to remain anonymous

Hello! We recently received an RRA request. It was from the same FDA auditor that we had in 2018, so we knew if was legitimate.  Attached is the information that we were sent (redacted) regarding the RRA and process.  It was pretty painless and we ended up with no findings - however, the auditor stressed that just because the RRA had no findings, doesn't mean that the FDA will not audit onsite.  The interesting item, was that in order to get a copy of the RRA report, you have to request it from FOIA.
Original Message:
Sent: 09-Mar-2021 15:14
From: Sheryl Brown-Shimer
Subject: FDA "voluntary" Remote Regulatory Assessment

​​Has anyone else been contacted by FDA for one of these?  said wont present a 482 nor  a 483 but might lead to an inspection.   It will be over 15 days - seems like a lot and is definitely more of a burden on a site than a 4 day inspection.   They said it was voluntary but it cant be moved and was 1 week notice.  Deciding whether to agree to it or not - wanted to know if others have experienced this.

------------------------------
Sheryl Brown-Shimer
Director Regulatory Affairs
Clinton MA
United States
------------------------------

In the case I mentioned in another Forum discussion on this topic, after assessing the firm's written operating procedures (to assess conformity with FDA's "defined and documented" criteria), FDA next requested various records (to assess conformity with FDA's "implemented" criterion).  Complaints, nonconforming product, CAPAs, internal audit evidence, supplier assessment evidence, calibration records, and the DMR are examples of the records requested.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 02-Aug-2021 08:38
From: Ed Panek
Subject: FDA "voluntary" Remote Regulatory Assessment

Thanks,

Were you able to respond to the questions verbally or were more documents required?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 30-Jul-2021 20:01
From: Anonymous Member
Subject: FDA "voluntary" Remote Regulatory Assessment

This message was posted by a user wishing to remain anonymous

In our particular case, I would estimate about 4 hours of document compilation and upload into the recommended FDA portal.  There was a 30-minute pre-meeting prior to the audit day as the auditor informed us of the documents they wanted to review. On the day of the RRA, we spent about two hours with the auditor answering their questions on the documents we submitted and a few other questions.  Your experience may be different, as our auditor was familiar with our devices/facility and we did not have a lot of changes from the 2018 audit, so I believe this made the RRA quicker.

We did submit a FOIA to the FDA for the RRA final report and received it within two-weeks of the request.  Hope this help.
Original Message:
Sent: 29-Jul-2021 15:24
From: Ed Panek
Subject: FDA "voluntary" Remote Regulatory Assessment

How many days and hours per day were required? Was there a lot of back and forth?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 22-Mar-2021 20:33
From: Anonymous Member
Subject: FDA "voluntary" Remote Regulatory Assessment

This message was posted by a user wishing to remain anonymous

Hello! We recently received an RRA request. It was from the same FDA auditor that we had in 2018, so we knew if was legitimate.  Attached is the information that we were sent (redacted) regarding the RRA and process.  It was pretty painless and we ended up with no findings - however, the auditor stressed that just because the RRA had no findings, doesn't mean that the FDA will not audit onsite.  The interesting item, was that in order to get a copy of the RRA report, you have to request it from FOIA.
Original Message:
Sent: 09-Mar-2021 15:14
From: Sheryl Brown-Shimer
Subject: FDA "voluntary" Remote Regulatory Assessment

​​Has anyone else been contacted by FDA for one of these?  said wont present a 482 nor  a 483 but might lead to an inspection.   It will be over 15 days - seems like a lot and is definitely more of a burden on a site than a 4 day inspection.   They said it was voluntary but it cant be moved and was 1 week notice.  Deciding whether to agree to it or not - wanted to know if others have experienced this.

------------------------------
Sheryl Brown-Shimer
Director Regulatory Affairs
Clinton MA
United States
------------------------------

Was this scope/agenda of their assessment?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 02-Aug-2021 12:27
From: Kevin Randall
Subject: FDA "voluntary" Remote Regulatory Assessment

In the case I mentioned in another Forum discussion on this topic, after assessing the firm's written operating procedures (to assess conformity with FDA's "defined and documented" criteria), FDA next requested various records (to assess conformity with FDA's "implemented" criterion).  Complaints, nonconforming product, CAPAs, internal audit evidence, supplier assessment evidence, calibration records, and the DMR are examples of the records requested.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 02-Aug-2021 08:38
From: Ed Panek
Subject: FDA "voluntary" Remote Regulatory Assessment

Thanks,

Were you able to respond to the questions verbally or were more documents required?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 30-Jul-2021 20:01
From: Anonymous Member
Subject: FDA "voluntary" Remote Regulatory Assessment

This message was posted by a user wishing to remain anonymous

In our particular case, I would estimate about 4 hours of document compilation and upload into the recommended FDA portal.  There was a 30-minute pre-meeting prior to the audit day as the auditor informed us of the documents they wanted to review. On the day of the RRA, we spent about two hours with the auditor answering their questions on the documents we submitted and a few other questions.  Your experience may be different, as our auditor was familiar with our devices/facility and we did not have a lot of changes from the 2018 audit, so I believe this made the RRA quicker.

We did submit a FOIA to the FDA for the RRA final report and received it within two-weeks of the request.  Hope this help.
Original Message:
Sent: 29-Jul-2021 15:24
From: Ed Panek
Subject: FDA "voluntary" Remote Regulatory Assessment

How many days and hours per day were required? Was there a lot of back and forth?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 22-Mar-2021 20:33
From: Anonymous Member
Subject: FDA "voluntary" Remote Regulatory Assessment

This message was posted by a user wishing to remain anonymous

Hello! We recently received an RRA request. It was from the same FDA auditor that we had in 2018, so we knew if was legitimate.  Attached is the information that we were sent (redacted) regarding the RRA and process.  It was pretty painless and we ended up with no findings - however, the auditor stressed that just because the RRA had no findings, doesn't mean that the FDA will not audit onsite.  The interesting item, was that in order to get a copy of the RRA report, you have to request it from FOIA.
Original Message:
Sent: 09-Mar-2021 15:14
From: Sheryl Brown-Shimer
Subject: FDA "voluntary" Remote Regulatory Assessment

​​Has anyone else been contacted by FDA for one of these?  said wont present a 482 nor  a 483 but might lead to an inspection.   It will be over 15 days - seems like a lot and is definitely more of a burden on a site than a 4 day inspection.   They said it was voluntary but it cant be moved and was 1 week notice.  Deciding whether to agree to it or not - wanted to know if others have experienced this.

------------------------------
Sheryl Brown-Shimer
Director Regulatory Affairs
Clinton MA
United States
------------------------------

This message was posted by a user wishing to remain anonymous

During the RRA conference call, we responded to any questions asked by the auditors. There were no unresolved questions for findings issued. No other documents were requested.  I suppose it is up to the auditor and/or the documentation presented as to whether or not there are any other actions.
Original Message:
Sent: 02-Aug-2021 08:38
From: Ed Panek
Subject: FDA "voluntary" Remote Regulatory Assessment

Thanks,

Were you able to respond to the questions verbally or were more documents required?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 30-Jul-2021 20:01
From: Anonymous Member
Subject: FDA "voluntary" Remote Regulatory Assessment

This message was posted by a user wishing to remain anonymous

In our particular case, I would estimate about 4 hours of document compilation and upload into the recommended FDA portal.  There was a 30-minute pre-meeting prior to the audit day as the auditor informed us of the documents they wanted to review. On the day of the RRA, we spent about two hours with the auditor answering their questions on the documents we submitted and a few other questions.  Your experience may be different, as our auditor was familiar with our devices/facility and we did not have a lot of changes from the 2018 audit, so I believe this made the RRA quicker.

We did submit a FOIA to the FDA for the RRA final report and received it within two-weeks of the request.  Hope this help.
Original Message:
Sent: 29-Jul-2021 15:24
From: Ed Panek
Subject: FDA "voluntary" Remote Regulatory Assessment

How many days and hours per day were required? Was there a lot of back and forth?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 22-Mar-2021 20:33
From: Anonymous Member
Subject: FDA "voluntary" Remote Regulatory Assessment

This message was posted by a user wishing to remain anonymous

Hello! We recently received an RRA request. It was from the same FDA auditor that we had in 2018, so we knew if was legitimate.  Attached is the information that we were sent (redacted) regarding the RRA and process.  It was pretty painless and we ended up with no findings - however, the auditor stressed that just because the RRA had no findings, doesn't mean that the FDA will not audit onsite.  The interesting item, was that in order to get a copy of the RRA report, you have to request it from FOIA.
Original Message:
Sent: 09-Mar-2021 15:14
From: Sheryl Brown-Shimer
Subject: FDA "voluntary" Remote Regulatory Assessment

​​Has anyone else been contacted by FDA for one of these?  said wont present a 482 nor  a 483 but might lead to an inspection.   It will be over 15 days - seems like a lot and is definitely more of a burden on a site than a 4 day inspection.   They said it was voluntary but it cant be moved and was 1 week notice.  Deciding whether to agree to it or not - wanted to know if others have experienced this.

------------------------------
Sheryl Brown-Shimer
Director Regulatory Affairs
Clinton MA
United States
------------------------------

Information FYI for those RAPS members who may have questions about the FDA RRA process.

• We are on day 3
• We may have a closing meeting today
• Usually, a 1-hour meeting starts the day with discussion and requests
• emailing requests. FDA can accept up to 100MB per email so adjust your email server accordingly
• On-Call from 9:30 to 3:30 for questions from FDA
• Top-Down - SOP to records
• Topics so far - CAPA, NCR, Complaints, Investigation, Corrections and MDR, Design Controls, A review of your latest design change, Training Specifically for Management Rep and meeting attendees and production key persons responsible for QC checks, Supplier approval and monitoring.
• A verbal closing meeting with any findings
• Have to FOIA the memo  from FDA written to document in your QMS 

Also, general request, should we start a RAPS_WIKI for things like this?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 02-Aug-2021 11:41
From: Anonymous Member
Subject: FDA "voluntary" Remote Regulatory Assessment

This message was posted by a user wishing to remain anonymous

During the RRA conference call, we responded to any questions asked by the auditors. There were no unresolved questions for findings issued. No other documents were requested.  I suppose it is up to the auditor and/or the documentation presented as to whether or not there are any other actions.
Original Message:
Sent: 02-Aug-2021 08:38
From: Ed Panek
Subject: FDA "voluntary" Remote Regulatory Assessment

Thanks,

Were you able to respond to the questions verbally or were more documents required?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 30-Jul-2021 20:01
From: Anonymous Member
Subject: FDA "voluntary" Remote Regulatory Assessment

This message was posted by a user wishing to remain anonymous

In our particular case, I would estimate about 4 hours of document compilation and upload into the recommended FDA portal.  There was a 30-minute pre-meeting prior to the audit day as the auditor informed us of the documents they wanted to review. On the day of the RRA, we spent about two hours with the auditor answering their questions on the documents we submitted and a few other questions.  Your experience may be different, as our auditor was familiar with our devices/facility and we did not have a lot of changes from the 2018 audit, so I believe this made the RRA quicker.

We did submit a FOIA to the FDA for the RRA final report and received it within two-weeks of the request.  Hope this help.
Original Message:
Sent: 29-Jul-2021 15:24
From: Ed Panek
Subject: FDA "voluntary" Remote Regulatory Assessment

How many days and hours per day were required? Was there a lot of back and forth?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 22-Mar-2021 20:33
From: Anonymous Member
Subject: FDA "voluntary" Remote Regulatory Assessment

This message was posted by a user wishing to remain anonymous

Hello! We recently received an RRA request. It was from the same FDA auditor that we had in 2018, so we knew if was legitimate.  Attached is the information that we were sent (redacted) regarding the RRA and process.  It was pretty painless and we ended up with no findings - however, the auditor stressed that just because the RRA had no findings, doesn't mean that the FDA will not audit onsite.  The interesting item, was that in order to get a copy of the RRA report, you have to request it from FOIA.
Original Message:
Sent: 09-Mar-2021 15:14
From: Sheryl Brown-Shimer
Subject: FDA "voluntary" Remote Regulatory Assessment

​​Has anyone else been contacted by FDA for one of these?  said wont present a 482 nor  a 483 but might lead to an inspection.   It will be over 15 days - seems like a lot and is definitely more of a burden on a site than a 4 day inspection.   They said it was voluntary but it cant be moved and was 1 week notice.  Deciding whether to agree to it or not - wanted to know if others have experienced this.

------------------------------
Sheryl Brown-Shimer
Director Regulatory Affairs
Clinton MA
United States
------------------------------