FDA has released final guidance detailing the types of actions, inaction, and circumstances that the agency considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection.
In July 2012, as part of FDASIA, FDA released statutory authority to deem drug products adulterated if a facility delays, denies, limits, or refuses to permit entry during an FDA inspection. On October 21, 2014, FDA issued Guidance for Industry: Circumstances that Constitute Delaying, Denying, Limiting or Refusing a Drug Inspection in order to explain what FDA considers to be circumstances that constitute violative delay, denial, limitation, or refusal.
Examples of delays during an inspection that may cause drugs to be adulterated under section 501(j) of the FD&C Act include, but are not limited to:
• A facility does not allow the FDA investigator access to an area of the facility until a specific future date or time even though the area is operational and is an area of the inspection site that FDA has authority to inspect, without giving a reasonable explanation.
• A facility leaves the FDA investigator in a conference room without access to necessary documentation or responsible individuals for an unreasonable period of time that interferes with the investigator’s ability to complete the inspection.
Examples of behavior that may constitute a denial that may cause drugs to be adulterated under section 501(j) of the FD&C Act include, but are not limited to:
• A facility rejects FDA’s attempt to schedule a pre-announced inspection.
• Upon arrival at the facility, the facility does not allow the FDA investigator to begin the inspection.
• A facility does not allow the FDA investigator to inspect the facility because certain staff members are not present, without a reasonable explanation.
• A facility does not allow the FDA investigator to inspect the facility by falsely alleging the facility does not manufacture, process, pack, or hold drugs.
• A facility sends staff home for the day and tells the FDA investigator that the facility is not producing any product.
Examples of an owner, operator, or agent refusing to permit entry or inspection include:
• Without reasonable explanation, the facility bars the FDA investigator from entering the facility or certain areas of the facility by, for example, not unlocking the areas or taking
other necessary actions that would permit access by the investigator.
• Following FDA’s attempt to contact the facility’s designated contact(s) to schedule an inspection, the facility fails to respond.
• The facility does not answer calls from the FDA investigator who is present at the facility, despite clear evidence of the presence of employees engaged in job-related
The guidance also provides several examples of potentially reasonable explanations that might not result in the drugs being deemed adulterated under section 501(j) of the FD&C Act.