What to Expect From an FDA Inspection, Part 2

June 14, 2021

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:

  • Initial request for a list of deviations, SAE’s, investigations, etc. These should be ready to be provided to the inspector soon after the tour.
  • Tour of the facility (processes, products, records, equipment, data sources, etc.). Be prepared for employees to be interviewed regarding their roles, anticipate drawers will be opened and waste/recycle bins will be inspected. First impressions are everything, ensure areas are clean, neat, and organized. Investigators will be evaluating the facility for key risks to patients and products.
  • Follow-up on any previous inspection responses, observations, or commitments.
  • Systematic inspection approach over a selection of the six quality systems, usually 3-4 of the following systems will be inspected depending on the type of inspection:
    • Quality System (this system will always be inspected)
    • Production
    • Facilities & Equipment
    • Laboratory Control
    • Materials
    • Packaging & Labeling
  • The investigator is permitted to review documents and records pertaining to the control, manufacturing, or quality assurance activities within the facility.
    • Be professional, polite, and cooperative, the inspector has the legal authority to inspect your facility.
    • Be truthful, answer questions with honesty, if you do not know, say so and do not guess. Refer to the corresponding SOP if unsure of an answer. All applicable employees should be familiar with their job’s required SOPs and know to always defer to the procedure if interviewed.
    • Be accepting and humble, take the opportunity to learn from the inspection and use it to improve your compliance.
  • There will be an Inspection Conclusion closeout meeting at the end of the inspection.
  • Any deficiencies will be noted and you may be issued a FDA Form 483 (List of Observations)

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.


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