FDA Policy/General

FDA Draft Guidance on Responses to FDA-483s Explained

Attorneys Nathan Brown and Maddy Bolger (Akin) say regulated industries should assess and incorporate the FDA suggestions in a 3/9 draft guidance, Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection, into their form FDA-483 response practices and, in particular, their corrective and preventive actions (CAPA) process, to the extent they have not already done so. In an online post, Brown and Bolger say the guidance is intended for foreign and domestic human and animal drug establishments manufacturing drugs regulated by CDER, CBER, and CVM, and also for combination product manufacturers for which CDER or CBER is the lead Center.

According to FDA, an FDA-483 response should show that an establishment has addressed or is addressing the observations and any underlying issues associated with the observations. The attorneys write that a key element of the draft’s recommendations includes an executive summary of all remediation activities with key details and a more detailed description of each observation and remediation activity.

“FDA recommends that the summary include patient- and product-focused risk assessments, assessing both inventory and distributed drugs and effects on safety, identity, strength, quality, and purity of potentially affected drugs; a detailed investigation report with scope, summary, a list of associated drugs and lot numbers, root causes and systemic issues, and a CAPA plan with applicable dates for completion, and attachments related to the associated observation, such as documents, pictures, video, diagrams, and data, which should be signed,” the post says. “FDA recommends a table for each executive summary. Finally, FDA recommends a discussion of each FDA 483 observation and other items as appropriate.”

The FDA draft guidance also includes recommendations for the ways in which observations are addressed.

The agency will receive comments on the draft guidance until 5/8.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome