Don’t Just Say “We’ll Fix It”: FDA Wants Real Investigations in Your 483 Response March 13, 2026 By Kalie E. Richardson & Charles D. Snow & Anne K. Walsh —

https://www.thefdalawblog.com/2026/03/dont-just-say-well-fix-it-fda-wants-real-investigations-in-your-483-response/?utm_source=rss&utm_medium=rss&utm_campaign=dont-just-say-well-fix-it-fda-wants-real-investigations-in-your-483-response In response to what FDA calls “inadequate responses to FDA 483 observations due to a lack or omission of relevant data, excessive amounts of data, and/or failure to address the root cause of observations,” the Agency published a new Draft Guidance on Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection. The Draft Guidance is applicable to inspections of all foreign and domestic human and animal drug manufacturers, including 503B outsourcing facilities and manufacturers of combination products where CDER or CBER is the lead center. FDA explains that the Draft Guidance explicitly does not apply to medical devices because the expectation that manufacturers thoroughly investigate unexplained discrepancies is a requirement specific to the drug CGMP regulations (21 CFR 211.192). However, medical device manufacturers also have a corresponding expectation that they conduct root cause investigations of nonconformities, and as FDA notes in footnote 3, CDRH has a similar expectation described in the Nonbinding Feedback After Certain FDA Inspections of Device Establishments Guidance (April 2020), which we covered previously.