How to Respond to FDA Form 483s and Warning Letters
July 10, 2017
Many medical device manufacturers receive FDA warning letters due to lack of preparation for the FDA inspection and/or an inadequate response to an FDA Form 483. The manner in which manufacturers respond to the 483 is critical in mitigating potential compliance risks and preventing the issuance of a warning letter. This article by NSF’s Kristen Grumet, published in Medical Design and Outsourcing, explains six key steps manufacturers can take when issued the FDA Form 483.
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