Tag Archives: Form 483s

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Responding to a Warning Letter

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

So your organization has received a warning letter from FDA – now what? For starters, the agency has quickly upped the ante in regards to taking the next steps in ensuring your organization clearly understands that a continued state of non-compliance is not acceptable. Warning letters are life-changing events for device manufacturers; however, they are recoverable. Dr. D recommends getting legal counsel and industry experts involved when responding to a warning letter, reviewing subsequent correspondence…

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Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Responding to a Form 483

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

There are two options in regards to Form 483s: in option One, an organization can be proactive, accept the Form 483, and treat is as an opportunity for pursuing continuous improvement, while driving compliance to the QSR. In option Two, an organization can ignore the Form 483, and in doing so, be prepared to deal with the proverbial opening of the can of “FDA worms” and the subsequent warning letter that will be issued.

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