In this continuation from “Preparing for an FDA Inspection” I will discuss what I have witnessed as a typical outline of events for FDA inspections.
Prior to setting foot at the facility, the FDA inspector will review the site file that they maintain on your firm. This will include information such as your establishment registration, your compliance history, informal verbal suggestions, formal issued 483 observations and corresponding responses. For Pre-Approval Inspections, the drug’s CMC section will be reviewed. Additionally, any reported items such as site metrics and adverse events will be reviewed beforehand. The FDA inspector will have a good understanding about the state of your business before arriving at your site.
When the inspector arrives, they will present a Notice of Inspection (FDA Form 482). This will describe the nature and circumstances of the visit. The FDA Form 482 will also indicate whether the inspection is for cause, a general maintenance visit for routine surveillance, or for product pre-approval. If by chance the inspection is pre-announced, be prepared to provide any previously requested documentation (e.g. information that supports drug application). Also, ensure that your site’s visitor and safety policy is followed (sign in, safety video, review of credentials, etc.), and escort the inspector to a designated inspection room.
The inspection will kick off with an introduction of key site individuals and then will likely flow as such:
Don’t wait until an inspector shows up at your door to prepare your site and systems. Be inspection ready at all times. Have an audit team and procedure in place that defines responsibilities and expectations for behavior during an audit. Maintain an updated facility/company overview presentation. Know your tour route (typically following material process flows). It is the seemingly small, everyday activities that add up to keep your site inspection ready, and your products safe and in compliance.
June 14, 2021
The most recent FDA report (FY2010) said the third highest reason a 483, warning letter, or consent decree was issued was because of discrepancies and/or failures in investigations due to inadequate...
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The FDA has an established policy that allows companies 15 days to respond in writing to the FDA after issuance of a 483 observation. More specifically, the written response must be received in the...
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On Thursday, September 13th, FDA published a proposed rule which would amend the current premarket submission requirements for medical devices. Background In July 2012, the Food and Drug...