Form 483 Responses Must Include Adequate Corrective Actions, Says FDA Official

Though there is no regulation requiring they do so, companies that receive an FDA Form 483 should always provide a response in writing that is well-organized, comprehensive and includes adequate corrective actions to addresses deficiencies, says Rebecca Asente, an FDA compliance officer with the Office of Regulatory Affairs.

“I’ve received responses that were out of order such that I had to contact the firm for a corrected, organized response package,” Asente remarked during an FDA webinar, What to Expect after an Inspection: 483s, Responses and Beyond, posted to the agency’s YouTube channel.

Gain more insights on postpandemic inspections from FDA officials, including Alonza Cruse, director of the Office of Pharmaceutical Quality Operations within the Office of Regulatory Affairs, keynote speaker at the 18th Annual FDA Inspections Summit produced by FDAnews, a WCG company, Nov. 8-9.

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