How to Develop A Narrative Summary of Remedial Actions When Responding to Inspectional Observations

FDA's Francis Godwin suggests firms avoid contextless "document dumps" when responding to a Form 483. Here's how to craft a compelling narrative summary.

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During the GMP by the Sea Conference held in August of this year, Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA's CDER, shared helpful information about the regulatory discretion exercised for drug manufacturing facilities with serious compliance problems.

He also discussed how firms should respond to FDA inspectional observations and mentioned upcoming guidance that will interest generic drug manufacturing firms that have received Warning Letters.

Here, we’d like to focus on Mr. Godwin’s advice regarding responding to FDA inspectional observations—expanding on it with some practical tips for acting on it.

If you’d like Mr. Godwin’s full presentation deck, you can access and download it below.