Denying, Delaying, And Refusing: How to Fail a FDA Inspection

The inspection of a facility by the FDA is based on certain rules and laws. During an on-site inspection, inspectors are entitled to request access to all documents and rooms connected to the manufacture of medicinal products and APIs for which a marketing authorisation application has been submitted or which are already marketed in the USA. Those rules are well-known and there exists many training programmes and seminars on how to prepare, accompany and behave during a FDA inspection.

Nevertheless, FDA inspections have to face again and again staff refusing any cooperation. The strategies resulting from such behaviours are quite always the same: intentional delaying (e.g. keep the inspector waiting for the documents he asked for), denying the access to certain rooms or documents, or completely refusing the inspection to be performed. 

In July 2013, the FDA published the "Guidance for Industry: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection". The Guidance is still in the draft stage and can be commented on the "Regulations.gov" page of the eRulemaking Program Management Office. The Guidance addresses the following topics: delay, denial of and limiting an inspection. It also describes the corresponding behaviour. Discontinuation of all manufacturing activities, or forbidding the copying of records and taking photographs are examples of limiting an inspection. The latter may lead to conflicts when a company guideline basically doesn't allow photography on the site.

The facts described in the Guidance document are already part of the legal framework. According to section 707 of the "Food and Drug Administration Safety and Innovation Act" (FDASIA) - a regulation which came into force on 9 July 2012 - all products are considered adulterated which have been manufactured in a factory where the owner of the factory delays or limits an inspection, or even refuses to permit an inspection (more details about the FDASIA can be found here). This is exactly the citation that can be found in two Warning Letters addressed to Indian companies on 1st July 2013 and 18 July 2013. Both Warning Letters contain detailed information about how inspectors have been limited in their work. Apart from the GMP violations observed during the inspection, the letters can be read as the perfect instruction on how to fail a FDA inspection.

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