How to Respond to FDA Form 483s and Warning Letters

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.