What should I expect during an FDA audit?

January 5, 2023

Under the Federal Food, Drug and Cosmetic Act, the FDA is required to inspect manufacturers at least once every two years - even more frequently with start-up companies, those with a history of compliance problems, and those which have begun producing products significantly different from what they produced before.

FDA may conduct an inspection of an operation for many reasons, such as a survey, routinely scheduled investigation, or a response to a reported problem. Regardless of the reason for the FDA's visit, a failed inspection may lead to a warning letter, seizure, injunction, criminal prosecution, and fines.

Arrival

Though investigators are not required to give notice of their arrival ahead of time, they still need to make their presence known when they arrive.

Once an investigator arrives at your facility, he or she will present credentials and a "Notice of Inspection" (FDA Form 482). This form gives the FDA the ability to audit the facility and contains a description of the investigator's expectations.

As the form is completed, it will be provided to top-level management or the highest-ranking person at the facility at the time.

Facility Inspection and Audit

When the FDA auditor conducts an inspection, he or she will note observations on Form 483. While the form contains the investigator's findings about any potential violations of the Food, Drug, & Cosmetic Act, it is not the investigator's final report.

Usually, the investigator will examine your production process, look at certain records and collect samples. If the investigator took any samples during the investigation, they must complete FDA Form 484 and provide it to the same individual who received form 482.

Closeout Meeting

At the conclusion of their audit, the investigator will meet with your company's management to review any findings and concerns; and leave with your management a written report of any conditions or practices, which, in the investigator's judgment, indicate objectionable conditions, or practices.

This list of "Inspectional Observations," also called an FDA Form 483, can be used by your company's management as a guide for corrective action since the FDA will not usually recommend specific corrective measures.

During the discussion with the FDA investigator, your company can respond to Form 483. In fact, corrective actions that were accomplished immediately following the investigation are considered positive indications of your desire to correct discrepancies.

Post-Inspection

After the inspection, your company will receive a letter from the FDA listing the inspector's findings. If regulatory deficiencies were found, they’ll be listed in the FDA form 483. In addition, the inspector will give a rough timeline by which any corrections should be made.

After your responses are received, the investigator will write and submit an Establishment Inspection Report to the compliance office. If major compliance problems or other kinds of legal violations were identified, the FDA will take further disciplinary actions as needed in the form of warning letters and further.

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Source:

https://www.fda.gov/industry/fda-basics-industry/what-should-i-expect-during-inspection