FDA 483 Observations: Should You Provide Copies to Clients?

Q: We’re a testing lab, and I’m completing a routine Quality Survey for one of our clients. They asked if we have received any FDA 483 observations from FDA inspectors and, if so, they would like a copy. Should we freely send a copy of FDA 483 observations to clients when requested?

A: It’s really up to you. When evaluating possible service providers, it’s not unusual for companies to use FDA 483s and other third-party findings in lieu of doing their own audits.

If you do send the client a copy of your 483, you should redact anything specific to any other of your clients. Even more importantly, be sure to include a copy of the 483 response you sent to the FDA, so your client knows what you’re doing to address the observation.

Answered by Denise Dion, EduQuest VP of Regulatory and Quality Services (18 years as an FDA investigator and lead instructor of EduQuest’s The CAPA Clinic: FDA Rules for Effective CAPA Systems, Failure Investigations, and Complaint Management training class).


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