Responding to FDA Form 483 and Warning Letters: Dos and Don’ts

Posted in Regulatory and Compliance by Jamie Hartford on February 3, 2014

Follow these six rules for responding to FDA’s inspectional observations and warning letters.



There is a scene in the old Rodney Dangerfield movie Back to School in which Dangerfield’s character, Thornton Melon, is preparing to take an oral exam from all his professors. One particularly stern lecturer rises and says, “I have only one question for Mr. Melon,” eliciting a relieved smile from the ill-prepared scholar—until the professor finishes his phrase: “…in 27 parts.”

Jonathan M. Lewis, principle of Advanced Biomedical Consulting, says FDA’s Form 483 and warning letters are much like that professor’s question.

“Lots of times FDA will throw out an issue and break it down into 15 parts, but it might only look like two paragraphs to a layman,” Lewis says. “Lots of times, [companies] don’t take the time to really break down each observation.”

But if medical device companies don’t address the agency’s concerns satisfactorily, they could find themselves in a world of trouble.

Lewis will be presenting 10 commandments for responding to Form 483 and warning letters in a session at the upcoming MD&M West conference. Here are a few of the dos and don’ts he’ll be covering:

Do respond in a timely fashion as soon as possible.

Do show a commitment to fixing the problems the agency raised in your response.

Do respond completely and address each observation completely, with a full corrective and preventive action.

Don’t use an overly argumentative tone in your response.

Don’t blame the problems on human resources or training issues.

Don’t try to interpret the regulations for FDA.

Learn more about how to respond appropriately to Form 483 and warning letters by attending Lewis's MD&M West conference session at 3:45 p.m. on Monday, Februrary 10, 2014, at the Anaheim Convention Center.

Jamie Hartford, managing editor, MD+DI


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