Summary
Enhanced Compliance Inc. is releasing this white paper to better inform the medical device industry about how to most effectively respond to objectionable findings from the FDA generated as a result of Agency inspections or investigations. The following recommendations are provided by Larry Spears, former Acting Office Director and Deputy Director of the FDA Center for Devices and Radiological Health (CDRH) based on his experience in those positions.
This white paper is divided into responses to the form FDA 483, Notice of ObjectionableConditions, issued by FDA at the close of an inspection and responses to Warning Letters issued as a result of inspections or other activities including investigations. Warning Letters for non-inspection findings are not addressed in this white paper. Responses to other types of FDA correspondence regarding violations of law or regulation such as Untitled Letters, are not addressed in this white paper other than a brief mention of what they are.
Company responses to FDA 483s and Warning Letters should be transparent, comprehensive, and timely while addressing not only listed citations but also any associated systemic issues. Incomplete, poorly documented, or antagonistic responses will likely lead to further scrutiny by the FDA.
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