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From Health Law Daily, July 15, 2013

FDA provides examples of actions that constitute delay, denial, limitation or refusal of inspection leading to adulterated drug products

By Anthony H. Nguyen, JD

The FDA issued a draft guidance titled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection” providing examples of circumstances that the agency would consider to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection (Notice, 78 FR 42387, July 15, 2013). Facilities found to have performed any of the actions described in the draft document would have their products deemed adulterated under FDA regulations.

Background. The Food and Drug Administration Safety and Innovation Act (FDASIA) added a new provision to the Food, Drug, and Cosmetic Act (FDC Act) regarding inspections that would make a drug adulterated. Under 21 U.S.C. 351(j), the FDA is required within one year of the enactment of FDASIA to issue a guidance defining the circumstances constituting a delay, denial, or limitation of an inspection, as well as address the refusal to permit entry or inspection.

Guidance information. The FDA did not interpret the four terms describing prohibited behavior in the draft guidance (delay, deny, limit, refuse) as mutually exclusive. Examples of delay in scheduling a pre-announced inspection that may cause drugs to be considered as adulterated include, but were not limited to: (1) a facility not agreeing to a proposed inspection start date and failing to provide a reasonable explanation for its failure to do so; (2) after scheduling an inspection, a facility failing to request a later start date without giving a reasonable explanation; or (3) failing to respond following the FDA’s attempt to contact the facility’s designated contact(s).

Limiting access to photography or copying of records would be considered by the agency as a limitation on inspection. Additionally, during an inspection, not permitting the FDA investigator access to an area until a specific future date or time, leaving the FDA investigator without access to necessary documentation or responsible individuals for unreasonable periods of time, or failing to produce records in a reasonable timeframe would constitute a delay that may cause a drug to be considered adulterated.

The FDA also addressed various denials or refusals of inspection, including but not limited to: (1) rejecting attempts to schedule an inspection; (2) refusing to permit the commencement of a pre-scheduled inspection: (3) refusing inspection until certain staff is present; or (4) falsely alleging that the facility did not manufacture drugs.

MainStory: TopStory AdulterationNews DrugBiologicalNews

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