Last week, FDA issued a guidance for industry on the circumstances that constitute delaying, denying, limiting, or refusing a drug inspection, as required by the FDASIA. In July 2013, FDA issued a draft guidance on the issue. In response to public comments on the draft guidance, FDA revised the final version to clarify the expectations regarding the types of actions, inaction, and circumstances under which FDA would consider a drug adulterated. Examples of delaying, denying, or limiting an inspection that may cause drugs to be adulterated include failing to produce requested records within the timeframe specified by FDA without reasonable explanation, preventing the FDA inspector from beginning the inspection, and restricting entry to a portion of the facility without reasonable explanation. The guidance also adds a nonexhaustive list of examples of what may constitute "reasonable explanations" for such actions, inactions, or circumstances that could otherwise be considered delaying, denying, or limiting inspection, or refusing to permit entry or inspection. For example, the guidance provides that a "potentially reasonable explanation" may include when a facility refuses to allow FDA investigators access to aseptic processing areas until the investigator accommodates the facility's documented gowning procedures.
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