Tips for a Successful FDA Inspection

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Usually, two inspectors perform a preapproval inspection (PAI), but it is very common in recent times that only one experienced person takes over the entire inspection, especially when follow-up inspections are conducted. Is there a team of two inspectors (female or male), one is usually responsible for the inspection of the quality systems, the other for the technical and scientific aspects. 

Usually, the inspectors stay abroad for 3 weeks, and perform inspections at three to five different organizations. A primary source of information for foreign inspectors regarding inspection regulations is the inspection manual Investigation Operations Manual 2014. Another important basis for aspects of traveling is the Guide to International Inspections and Travel, updated version 2009. 

As part of the preparation, it is important to clarify with the FDA, and/or licensing partners, customers, which products are focused by the planned inspection to enable concentrated preparatory activities on these product(s). In the case of an initial inspection, besides the inspection of the product-related issues, a general and coherent good manufacturing practice (GMP) inspection is carried out in the target organization. This may well mean that other areas that are regulated by the Act 21 CFR 211, are inspected, because the inspection focuses on all products or processes potentially destined for the American market. 

1) http //www.fda.gov/ICECI/Inspections/FieldMan ementDirectives/ucm096034.htm. 

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