Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I recently submitted a 483 response via email for the first time. I submitted 3 separate emails because of the attachments but only got one acknowledgement from ORA. All 3 emails were within the size limits defined by FDA. Should I have received 3 separate acks?

Thanks

In this case it would seem appropriate to send a 4th email to the FDA office asking for confirmation that the the first 3 emails, with large attachments, were actually received.

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Peter Smith
Principal
Smith GMP Consulting
Narragansett, Rhode Island
USA
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Original Message:
Sent: 20-Aug-2018 15:14
From: Anonymous Member
Subject: Submitting 483 Response to FDA via email

This message was posted by a user wishing to remain anonymous

I recently submitted a 483 response via email for the first time. I submitted 3 separate emails because of the attachments but only got one acknowledgement from ORA. All 3 emails were within the size limits defined by FDA. Should I have received 3 separate acks?

Thanks

Agree with Peter that a fourth email is warranted. However, would suggest that you be very specific that you are looking for acknowledgement of receipt of the other emails, which had large attachments - then thank them for sending the initial acknowledgement.

Usually you'll just receive the one acknowledgement for the entire set of emails. Also, since I'm assuming your 483 response contained references to the attachments that the District (and Center Compliance folks) would reach out to you quickly if something was missing. Because without the attachments they could not perform a thorough review of your response. 

Good luck! 

Thanks, 

Steve

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Steven Lynn
Principal Consultant/Owner
Lynn Consulting, LLC
Silver Spring MD
United States
steven.lynn@gxp-quality.com

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Original Message:
Sent: 20-Aug-2018 15:14
From: Anonymous Member
Subject: Submitting 483 Response to FDA via email

This message was posted by a user wishing to remain anonymous

I recently submitted a 483 response via email for the first time. I submitted 3 separate emails because of the attachments but only got one acknowledgement from ORA. All 3 emails were within the size limits defined by FDA. Should I have received 3 separate acks?

Thanks

This message was posted by a user wishing to remain anonymous

May I know what FDA email Address you have used for the correspondence? 

I just want to know for my knowledge purpose.

Thank you,
Original Message:
Sent: 21-Aug-2018 12:14
From: Steven Lynn
Subject: Submitting 483 Response to FDA via email

Agree with Peter that a fourth email is warranted. However, would suggest that you be very specific that you are looking for acknowledgement of receipt of the other emails, which had large attachments - then thank them for sending the initial acknowledgement.

Usually you'll just receive the one acknowledgement for the entire set of emails. Also, since I'm assuming your 483 response contained references to the attachments that the District (and Center Compliance folks) would reach out to you quickly if something was missing. Because without the attachments they could not perform a thorough review of your response.

Good luck!

Thanks,

Steve

------------------------------
Steven Lynn
Principal Consultant/Owner
Lynn Consulting, LLC
Silver Spring MD
United States
steven.lynn@gxp-quality.com


Original Message:
Sent: 20-Aug-2018 15:14
From: Anonymous Member
Subject: Submitting 483 Response to FDA via email

This message was posted by a user wishing to remain anonymous

I recently submitted a 483 response via email for the first time. I submitted 3 separate emails because of the attachments but only got one acknowledgement from ORA. All 3 emails were within the size limits defined by FDA. Should I have received 3 separate acks?

Thanks

In the past I have received a single response, which referenced the number of emails they received. However, in my emails I had requested that they provide such acknowledgement. I would reach out just in case to confirm receipt of the full set of emails.

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Sabina Bruehlmann
Director Technology
Calgary AB
Canada
------------------------------

Original Message:
Sent: 20-Aug-2018 15:14
From: Anonymous Member
Subject: Submitting 483 Response to FDA via email

This message was posted by a user wishing to remain anonymous

I recently submitted a 483 response via email for the first time. I submitted 3 separate emails because of the attachments but only got one acknowledgement from ORA. All 3 emails were within the size limits defined by FDA. Should I have received 3 separate acks?

Thanks

In my experience, when sending multiple emails to any Regulatory Agencies, you will need to specify "1 of x" emails being sent and with an explanation of why.  This helps them organize your files better on their end.  In addition, in the body of your email(s), make a request for them provide acknowledge of receipt of all emails.  FDA is reasonable if you lay out your expectations.  In your case, it will warrant a 4^th email asking for the acknowledge and listing the # of emails, subject of emails, and time/date sent.

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Tran Do
Consultant
United States
www.qservegroup.com
------------------------------

Original Message:
Sent: 20-Aug-2018 15:14
From: Anonymous Member
Subject: Submitting 483 Response to FDA via email

This message was posted by a user wishing to remain anonymous

I recently submitted a 483 response via email for the first time. I submitted 3 separate emails because of the attachments but only got one acknowledgement from ORA. All 3 emails were within the size limits defined by FDA. Should I have received 3 separate acks?

Thanks

This message was posted by a user wishing to remain anonymous

Thanks everyone for your comments......

I did send the emails as "1 of 3", "2 of 3" etc etc so it was clear how many were being submitted.
I received an email from FDA (Division 3 West) yesterday confirming receipt of all three emails. I think they did this because I called and left a voicemail asking specifically for confirmation. As someone suggested above, I think normal practice is to send only one email acknowledgement.
Original Message:
Sent: 21-Aug-2018 14:36
From: Tran Do
Subject: Submitting 483 Response to FDA via email

In my experience, when sending multiple emails to any Regulatory Agencies, you will need to specify "1 of x" emails being sent and with an explanation of why.  This helps them organize your files better on their end.  In addition, in the body of your email(s), make a request for them provide acknowledge of receipt of all emails.  FDA is reasonable if you lay out your expectations.  In your case, it will warrant a 4^th email asking for the acknowledge and listing the # of emails, subject of emails, and time/date sent.

------------------------------
Tran Do
Consultant
United States
www.qservegroup.com

Original Message:
Sent: 20-Aug-2018 15:14
From: Anonymous Member
Subject: Submitting 483 Response to FDA via email

This message was posted by a user wishing to remain anonymous

I recently submitted a 483 response via email for the first time. I submitted 3 separate emails because of the attachments but only got one acknowledgement from ORA. All 3 emails were within the size limits defined by FDA. Should I have received 3 separate acks?

Thanks