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FDA’s Definition of Unacceptable Behaviour During its Audits
(Thursday, June 27, 2024) FDA inspections are intimidating events. The audited parties could intentionally or unintentionally behave in ways that are deemed as delaying, denying, limiting or refusing inspection by the FDA inspectors which are all illegal activities with serious consequences. Most of these issue emnate from the mispercetions regarding the rights of the audited parties during such audits. An updated guidance document from FDA describes specifics of what it deems to be one of those illegal activities duing an FDA audit by the regulated companies. The regulations authorize FDA to conduct inspections at “reasonable times, within reasonable limits, and in a reasonable manner” without defining “reasonable”. This has led some confusion with the audited parties about what is “reasonable”. The FDA considers this to mean what is “reasonably necessary to achieve the objective of the inspection”, and while the industry may interpret it to mean that it has some flexibility within the regulations about how it interacts with the FDA inspectors without being considered to be delaying, denying, limiting, or refusing an inspection. The FDA’s new guidance aims to give examples and scenarios to help clarify the best practices for the audited parties to be followed during an FDA audit. This guidance builds upon a previous guidance document on the same topic from ten years ago. The FDA doesn’t have to pre-announce inspections at drug facilities, but it usually does for pre-approval, pre-license, and most foreign inspections. For device facilities, pre-announcements are required for most inspections. Unreasonable and unexplained delays in agreeing to inspection dates or not responding to FDA’s contact is acceptable to the FDA. Things such as keeping the FDA inspectors wait unnecessarily, delays in providing requested records, and asking the FDA to delay pre-announced inspections by long periods of time are all examples of events that would be deemed unacceptable by the FDA. Misleading or impeding the inspection, not allowing entry or lying about manufacturing products, or rejecting an inspection are examples of behaviour considered by the FDA to be denying the inspection. Audited parties are not allowed to restrict inspector’s access to any areas of the facility, stopping production to hide those activities from the FDA, preventing photography, not allowing copying of documents, or prohibiting collection of samples. It is ok to ask FDA inspectors to follow the facility’s SOPs for access to clean rooms, use gowns and other personal protective equipment while accessing clean rooms, or request other reasonable conditions to maintain the integrity of the site’s operations during an FDA audit. FDA defines “refusal of inspection” as times when the establishment does not unlock, does not allow entry of the inspectors, or not respond or ignore calls from the FDA to schedule an inspection. All the examples given by the FDA in this new guidance document are based on what the FDA inspectors have faced during audits. None of the examples provided by the FDA should appear unreasonable. The short tip to the regulated industry, make the visit by the FDA inspectors easy for them, or face consequences. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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