Regulatory Open Forum

I have been asked to provide an update on remote regulatory inspections as well as requests for records in advance of inspection. If anyone has experience with this, can you post here or contact me? I'd appreciate your experience and insight. Thank you.

------------------------------
Andrea Chamblee Esq., RAC, FRAPS
Associate adjunct professor, George Washington University School of Medicine and Public Health.


Silver Spring MD
United States
------------------------------

For the U.S. medical device jurisdiction, a client and I a couple weeks ago went through an FDA Remote Regulatory Assessment (RRA).  Here's a recap:

FDA contacted the firm and informed them that, due to the current SARS-CoV-2 (COVID-19) situation, the FDA is conducting inspections [called Remote Regulatory Assessment (RRA)] on a limited basis at this time.  FDA proposed a date for conducting the RRA.  FDA explained that an RRA is a review of records and information provided by the inspected firm to gain information and to evaluate the firm's Quality System.  The RRA was conducted by a Consumer Safety Officer.

FDA states that the RRA is a voluntary activity that will not result in regulatory action due to non-participation.  RRAs may be limited in scope or terminated at the discretion of the Agency. The RRA is limited to reviewing information that can be provided electronically.  FDA says that the firm's ability to do so should factor into its decision for participation.

Refusal to provide information during the RRA is not a refusal under FDA's inspection authority found in Section 704 of the Act (21 USC 374).  Similarly, FDA does not present a Form FDA 482 at the beginning of the RRA, nor does FDA issue a Form FDA 483 at the end even if objectionable conditions are discovered during the RRA. At the conclusion of the RRA, a discussion of findings is held with management officials describing any items FDA wants to bring to the firm's attention.

Here comes the caveat:  Based on the outcome of findings from the RRA, FDA may consider "further communication and/or action". If significant deficiencies are noted, FDA may begin an onsite regulatory inspection for the purpose of protecting public health.  If that's necessary, then the designated management official will be notified.

We found the RRA to be very informal and pleasant (just short of a trip to the dentist), where information was exchanged merely via telephone and email.  For example, no online meeting platform was used.

Attached is an example of the information boilerplate that FDA disseminates when it initiates an RRA.  The attached came out of OMDRHO Division 2, but my RRA that I mentioned above came out of Division 3 (West) and the Los Angeles District Office.

Looking forward to hearing others' experiences.  This should be a very interesting thread.

------------------------------
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: 16-Jul-2021 16:29
From: Andrea Chamblee
Subject: Have you participated in an inspection that was remotely conducted, in whole or in part?

I have been asked to provide an update on remote regulatory inspections as well as requests for records in advance of inspection. If anyone has experience with this, can you post here or contact me? I'd appreciate your experience and insight. Thank you.

------------------------------
Andrea Chamblee Esq., RAC, FRAPS
Associate adjunct professor, George Washington University School of Medicine and Public Health.


Silver Spring MD
United States
------------------------------

Thank you for the recap. That's really helpful information.

------------------------------
Andrea Chamblee Esq., RAC, FRAPS

------------------------------

Original Message:
Sent: 16-Jul-2021 17:22
From: Kevin Randall
Subject: Have you participated in an inspection that was remotely conducted, in whole or in part?

For the U.S. medical device jurisdiction, a client and I a couple weeks ago went through an FDA Remote Regulatory Assessment (RRA).  Here's a recap:

FDA contacted the firm and informed them that, due to the current SARS-CoV-2 (COVID-19) situation, the FDA is conducting inspections [called Remote Regulatory Assessment (RRA)] on a limited basis at this time.  FDA proposed a date for conducting the RRA.  FDA explained that an RRA is a review of records and information provided by the inspected firm to gain information and to evaluate the firm's Quality System.  The RRA was conducted by a Consumer Safety Officer.

FDA states that the RRA is a voluntary activity that will not result in regulatory action due to non-participation.  RRAs may be limited in scope or terminated at the discretion of the Agency. The RRA is limited to reviewing information that can be provided electronically.  FDA says that the firm's ability to do so should factor into its decision for participation.

Refusal to provide information during the RRA is not a refusal under FDA's inspection authority found in Section 704 of the Act (21 USC 374).  Similarly, FDA does not present a Form FDA 482 at the beginning of the RRA, nor does FDA issue a Form FDA 483 at the end even if objectionable conditions are discovered during the RRA. At the conclusion of the RRA, a discussion of findings is held with management officials describing any items FDA wants to bring to the firm's attention.

Here comes the caveat:  Based on the outcome of findings from the RRA, FDA may consider "further communication and/or action". If significant deficiencies are noted, FDA may begin an onsite regulatory inspection for the purpose of protecting public health.  If that's necessary, then the designated management official will be notified.

We found the RRA to be very informal and pleasant (just short of a trip to the dentist), where information was exchanged merely via telephone and email.  For example, no online meeting platform was used.

Attached is an example of the information boilerplate that FDA disseminates when it initiates an RRA.  The attached came out of OMDRHO Division 2, but my RRA that I mentioned above came out of Division 3 (West) and the Los Angeles District Office.

Looking forward to hearing others' experiences.  This should be a very interesting thread.

------------------------------
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: 16-Jul-2021 16:29
From: Andrea Chamblee
Subject: Have you participated in an inspection that was remotely conducted, in whole or in part?

I have been asked to provide an update on remote regulatory inspections as well as requests for records in advance of inspection. If anyone has experience with this, can you post here or contact me? I'd appreciate your experience and insight. Thank you.

------------------------------
Andrea Chamblee Esq., RAC, FRAPS
Associate adjunct professor, George Washington University School of Medicine and Public Health.


Silver Spring MD
United States
------------------------------

Update on the FDA RRA I mentioned:  FDA ultimately turned to Zoom for conducting the remainder of the RRA after initial email and telephone correspondence.  Also, there was no virtual walk-around of the facility.  In addition, I forgot to mention that FDA said they were offering the RRAs to firms based on risk, meaning that high-risk firms (e.g., high risk class, poor past inspection results, etc.) would not generally be eligible for the RRA process.  When all was said and done, three partial days (few hours per day) was spent in the assessment.  Finally, the best news of all:  FDA said that the RRA would satisfy the statutory inspectional requirement, thus resetting the firm's cycle/queue for inspection assignments made via FDA's inspection scheduling system (e.g., in FACTS).

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

Original Message:
Sent: 16-Jul-2021 17:22
From: Kevin Randall
Subject: Have you participated in an inspection that was remotely conducted, in whole or in part?

For the U.S. medical device jurisdiction, a client and I a couple weeks ago went through an FDA Remote Regulatory Assessment (RRA).  Here's a recap:

FDA contacted the firm and informed them that, due to the current SARS-CoV-2 (COVID-19) situation, the FDA is conducting inspections [called Remote Regulatory Assessment (RRA)] on a limited basis at this time.  FDA proposed a date for conducting the RRA.  FDA explained that an RRA is a review of records and information provided by the inspected firm to gain information and to evaluate the firm's Quality System.  The RRA was conducted by a Consumer Safety Officer.

FDA states that the RRA is a voluntary activity that will not result in regulatory action due to non-participation.  RRAs may be limited in scope or terminated at the discretion of the Agency. The RRA is limited to reviewing information that can be provided electronically.  FDA says that the firm's ability to do so should factor into its decision for participation.

Refusal to provide information during the RRA is not a refusal under FDA's inspection authority found in Section 704 of the Act (21 USC 374).  Similarly, FDA does not present a Form FDA 482 at the beginning of the RRA, nor does FDA issue a Form FDA 483 at the end even if objectionable conditions are discovered during the RRA. At the conclusion of the RRA, a discussion of findings is held with management officials describing any items FDA wants to bring to the firm's attention.

Here comes the caveat:  Based on the outcome of findings from the RRA, FDA may consider "further communication and/or action". If significant deficiencies are noted, FDA may begin an onsite regulatory inspection for the purpose of protecting public health.  If that's necessary, then the designated management official will be notified.

We found the RRA to be very informal and pleasant (just short of a trip to the dentist), where information was exchanged merely via telephone and email.  For example, no online meeting platform was used.

Attached is an example of the information boilerplate that FDA disseminates when it initiates an RRA.  The attached came out of OMDRHO Division 2, but my RRA that I mentioned above came out of Division 3 (West) and the Los Angeles District Office.

Looking forward to hearing others' experiences.  This should be a very interesting thread.

------------------------------
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: 16-Jul-2021 16:29
From: Andrea Chamblee
Subject: Have you participated in an inspection that was remotely conducted, in whole or in part?

I have been asked to provide an update on remote regulatory inspections as well as requests for records in advance of inspection. If anyone has experience with this, can you post here or contact me? I'd appreciate your experience and insight. Thank you.

------------------------------
Andrea Chamblee Esq., RAC, FRAPS
Associate adjunct professor, George Washington University School of Medicine and Public Health.


Silver Spring MD
United States
------------------------------

Thank you!

------------------------------
Andrea Chamblee Esq., RAC, FRAPS

Silver Spring MD
United States
------------------------------

Original Message:
Sent: 19-Jul-2021 19:48
From: Kevin Randall
Subject: Have you participated in an inspection that was remotely conducted, in whole or in part?

Update on the FDA RRA I mentioned:  FDA ultimately turned to Zoom for conducting the remainder of the RRA after initial email and telephone correspondence.  Also, there was no virtual walk-around of the facility.  In addition, I forgot to mention that FDA said they were offering the RRAs to firms based on risk, meaning that high-risk firms (e.g., high risk class, poor past inspection results, etc.) would not generally be eligible for the RRA process.  When all was said and done, three partial days (few hours per day) was spent in the assessment.  Finally, the best news of all:  FDA said that the RRA would satisfy the statutory inspectional requirement, thus resetting the firm's cycle/queue for inspection assignments made via FDA's inspection scheduling system (e.g., in FACTS).

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

Original Message:
Sent: 16-Jul-2021 17:22
From: Kevin Randall
Subject: Have you participated in an inspection that was remotely conducted, in whole or in part?

For the U.S. medical device jurisdiction, a client and I a couple weeks ago went through an FDA Remote Regulatory Assessment (RRA).  Here's a recap:

FDA contacted the firm and informed them that, due to the current SARS-CoV-2 (COVID-19) situation, the FDA is conducting inspections [called Remote Regulatory Assessment (RRA)] on a limited basis at this time.  FDA proposed a date for conducting the RRA.  FDA explained that an RRA is a review of records and information provided by the inspected firm to gain information and to evaluate the firm's Quality System.  The RRA was conducted by a Consumer Safety Officer.

FDA states that the RRA is a voluntary activity that will not result in regulatory action due to non-participation.  RRAs may be limited in scope or terminated at the discretion of the Agency. The RRA is limited to reviewing information that can be provided electronically.  FDA says that the firm's ability to do so should factor into its decision for participation.

Refusal to provide information during the RRA is not a refusal under FDA's inspection authority found in Section 704 of the Act (21 USC 374).  Similarly, FDA does not present a Form FDA 482 at the beginning of the RRA, nor does FDA issue a Form FDA 483 at the end even if objectionable conditions are discovered during the RRA. At the conclusion of the RRA, a discussion of findings is held with management officials describing any items FDA wants to bring to the firm's attention.

Here comes the caveat:  Based on the outcome of findings from the RRA, FDA may consider "further communication and/or action". If significant deficiencies are noted, FDA may begin an onsite regulatory inspection for the purpose of protecting public health.  If that's necessary, then the designated management official will be notified.

We found the RRA to be very informal and pleasant (just short of a trip to the dentist), where information was exchanged merely via telephone and email.  For example, no online meeting platform was used.

Attached is an example of the information boilerplate that FDA disseminates when it initiates an RRA.  The attached came out of OMDRHO Division 2, but my RRA that I mentioned above came out of Division 3 (West) and the Los Angeles District Office.

Looking forward to hearing others' experiences.  This should be a very interesting thread.

------------------------------
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: 16-Jul-2021 16:29
From: Andrea Chamblee
Subject: Have you participated in an inspection that was remotely conducted, in whole or in part?

I have been asked to provide an update on remote regulatory inspections as well as requests for records in advance of inspection. If anyone has experience with this, can you post here or contact me? I'd appreciate your experience and insight. Thank you.

------------------------------
Andrea Chamblee Esq., RAC, FRAPS
Associate adjunct professor, George Washington University School of Medicine and Public Health.


Silver Spring MD
United States
------------------------------

Since we're in New Zealand, but our NB is in the US, we've had all of our audits since last year conducted remotely.  It's worked extremely well - we've even refined our method to do conduct walkthroughs of our warehouse and certain bits of our manufacturing facility using mobile phones. 

Plus, it's saved buckets of $$ on travel expenses...

------------------------------
Tina O'Brien RAC, MS
Director of Regulatory Affairs
Airport Oaks
New Zealand
------------------------------

Original Message:
Sent: 16-Jul-2021 16:29
From: Andrea Chamblee
Subject: Have you participated in an inspection that was remotely conducted, in whole or in part?

I have been asked to provide an update on remote regulatory inspections as well as requests for records in advance of inspection. If anyone has experience with this, can you post here or contact me? I'd appreciate your experience and insight. Thank you.

------------------------------
Andrea Chamblee Esq., RAC, FRAPS
Associate adjunct professor, George Washington University School of Medicine and Public Health.


Silver Spring MD
United States
------------------------------

I hosted a virtual GCP inspection of two foreign clinical investigator sites at our office. We were asked to obtain "certified" copies of study files. The investigators were interviewed on Zoom at the beginning and end of the "inspection". Documents from the sites were scanned and presented to the FDA investigator in our conference room with a translator online.

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

Original Message:
Sent: 16-Jul-2021 16:29
From: Andrea Chamblee
Subject: Have you participated in an inspection that was remotely conducted, in whole or in part?

I have been asked to provide an update on remote regulatory inspections as well as requests for records in advance of inspection. If anyone has experience with this, can you post here or contact me? I'd appreciate your experience and insight. Thank you.

------------------------------
Andrea Chamblee Esq., RAC, FRAPS
Associate adjunct professor, George Washington University School of Medicine and Public Health.


Silver Spring MD
United States
------------------------------

This message was posted by a user wishing to remain anonymous

We have hosted several remote inspections since the pandemic began in 2020.  The most recent being our MDSAP re-certification. These have run in similar fashion to on-site inspections, with the primary differences being virtual plant tours or video plant tours, up front procedure requests and file sharing set ups which can be complex given the company requirements for proprietary documents and electronic file sharing.
Original Message:
Sent: 19-Jul-2021 08:49
From: Glen Park
Subject: Have you participated in an inspection that was remotely conducted, in whole or in part?

I hosted a virtual GCP inspection of two foreign clinical investigator sites at our office. We were asked to obtain "certified" copies of study files. The investigators were interviewed on Zoom at the beginning and end of the "inspection". Documents from the sites were scanned and presented to the FDA investigator in our conference room with a translator online.

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

Original Message:
Sent: 16-Jul-2021 16:29
From: Andrea Chamblee
Subject: Have you participated in an inspection that was remotely conducted, in whole or in part?

I have been asked to provide an update on remote regulatory inspections as well as requests for records in advance of inspection. If anyone has experience with this, can you post here or contact me? I'd appreciate your experience and insight. Thank you.

------------------------------
Andrea Chamblee Esq., RAC, FRAPS
Associate adjunct professor, George Washington University School of Medicine and Public Health.


Silver Spring MD
United States
------------------------------

Lessons learned here:

• It's ok to decline this FDA offer of this RRA but it could cause an earlier onsite
• Passing the RRA pushes your audit scheduled to some # of years later
• No 483 are possible but if major violations are found could trigger an immediate onsite audit
• 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

We waited for 2 weeks post-closing of audit as suggested by our auditor for FOIA; big mistake. I suggest 4 or more weeks post-audit to submit. We were told the records were not ready and to cancel our request (This is so the FDA response times look better, Ack!). We were then told to resubmit in 60 days.

Will update this thread so we progress.

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

Original Message:
Sent: 24-Jul-2021 21:25
From: Anonymous Member
Subject: Have you participated in an inspection that was remotely conducted, in whole or in part?

This message was posted by a user wishing to remain anonymous

We have hosted several remote inspections since the pandemic began in 2020.  The most recent being our MDSAP re-certification. These have run in similar fashion to on-site inspections, with the primary differences being virtual plant tours or video plant tours, up front procedure requests and file sharing set ups which can be complex given the company requirements for proprietary documents and electronic file sharing.
Original Message:
Sent: 19-Jul-2021 08:49
From: Glen Park
Subject: Have you participated in an inspection that was remotely conducted, in whole or in part?

I hosted a virtual GCP inspection of two foreign clinical investigator sites at our office. We were asked to obtain "certified" copies of study files. The investigators were interviewed on Zoom at the beginning and end of the "inspection". Documents from the sites were scanned and presented to the FDA investigator in our conference room with a translator online.

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

Original Message:
Sent: 16-Jul-2021 16:29
From: Andrea Chamblee
Subject: Have you participated in an inspection that was remotely conducted, in whole or in part?

I have been asked to provide an update on remote regulatory inspections as well as requests for records in advance of inspection. If anyone has experience with this, can you post here or contact me? I'd appreciate your experience and insight. Thank you.

------------------------------
Andrea Chamblee Esq., RAC, FRAPS
Associate adjunct professor, George Washington University School of Medicine and Public Health.


Silver Spring MD
United States
------------------------------

We made out FOIA request on October 1, 2021, It's now a month out with no response yet. This was expected but I wanted to provide an update to others post-RRA and FOIA requests as to what to expect wrt timing. I Will update later.

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

Original Message:
Sent: 26-Aug-2021 08:33
From: Ed Panek
Subject: Have you participated in an inspection that was remotely conducted, in whole or in part?

Lessons learned here:

• It's ok to decline this FDA offer of this RRA but it could cause an earlier onsite
• Passing the RRA pushes your audit scheduled to some # of years later
• No 483 are possible but if major violations are found could trigger an immediate onsite audit
• 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

We waited for 2 weeks post-closing of audit as suggested by our auditor for FOIA; big mistake. I suggest 4 or more weeks post-audit to submit. We were told the records were not ready and to cancel our request (This is so the FDA response times look better, Ack!). We were then told to resubmit in 60 days.

Will update this thread so we progress.

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

Original Message:
Sent: 24-Jul-2021 21:25
From: Anonymous Member
Subject: Have you participated in an inspection that was remotely conducted, in whole or in part?

This message was posted by a user wishing to remain anonymous

We have hosted several remote inspections since the pandemic began in 2020.  The most recent being our MDSAP re-certification. These have run in similar fashion to on-site inspections, with the primary differences being virtual plant tours or video plant tours, up front procedure requests and file sharing set ups which can be complex given the company requirements for proprietary documents and electronic file sharing.
Original Message:
Sent: 19-Jul-2021 08:49
From: Glen Park
Subject: Have you participated in an inspection that was remotely conducted, in whole or in part?

I hosted a virtual GCP inspection of two foreign clinical investigator sites at our office. We were asked to obtain "certified" copies of study files. The investigators were interviewed on Zoom at the beginning and end of the "inspection". Documents from the sites were scanned and presented to the FDA investigator in our conference room with a translator online.

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

Original Message:
Sent: 16-Jul-2021 16:29
From: Andrea Chamblee
Subject: Have you participated in an inspection that was remotely conducted, in whole or in part?

I have been asked to provide an update on remote regulatory inspections as well as requests for records in advance of inspection. If anyone has experience with this, can you post here or contact me? I'd appreciate your experience and insight. Thank you.

------------------------------
Andrea Chamblee Esq., RAC, FRAPS
Associate adjunct professor, George Washington University School of Medicine and Public Health.


Silver Spring MD
United States
------------------------------