Hello Anon,
There is no specific requirement to OCR the file, but having a PDF file searchable is probably more important. Some documents might not be too readily OCR "able" either such as hard copy Device History Records - manufacturing records. If there are large documents, many pages, having them searchable is quite key to allow the reviewer to see specific information.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 24-Oct-2023 11:09
From: Kevin Randall
Subject: 483 response
The attached files to a response for a Form FDA-483 are not required to be in OCR format. But the FDA nonetheless definitely prefers the response to be submitted in electronic format via email. But I'd say FDA certainly doesn't mind if the response is in OCR format so as to help FDA search through the documents.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 24-Oct-2023 01:08
From: Anonymous Member
Subject: 483 response
This message was posted by a user wishing to remain anonymous
Does anyone know if attached files to the response for Form 483 must be in OCR format?