Under the Food and Drug Administration Safety and Innovation Act (FDASIA), the U.S. Food and Drug Administration (FDA) may deem a drug adulterated if that drug is “manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” In October 2014, FDA released “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection,” a finalized version of a draft guidance FDA published in July 2013, to clarify the conditions under which a drug may be deemed adulterated, as well as conditions under which FDA may find delays, denials, limits, or refusals to be reasonable actions of the owner.
Below are circumstances described in FDA’s guidance. The circumstances listed in the guidance are not meant to represent all possible scenarios, but rather commonly encountered ones.
What circumstances may lead to a drug being deemed adulterated?
- Refusing an FDA inspector entrance into a facility
- Failure to agree to a proposed inspection date with no reasonable explanation
- Trying to postpone a scheduled inspection date with no reasonable explanation
- Denying an FDA inspector access to an operational area of a facility with no reasonable explanation
- Leaving an FDA inspector in a conference room without access to necessary documentation or responsible individuals for an unreasonable period of time
- Failing to provide requested files to FDA with no reasonable explanation, despite being given a reasonable timeframe
- Disallowing an FDA inspector to begin the inspection upon arrival at the facility
- Disallowing an FDA inspector to inspect a facility because certain staff members are not present, without a reasonable explanation
- Falsely stating a facility does not manufacture, process, pack, or hold drugs
- Sending staff home on the day FDA plans to inspect and stating the facility is not producing any product
- Discontinuing manufacturing for the duration of an FDA inspection without reasonable explanation
- Limiting FDA’s observation to only a portion of the manufacturing process, or only allowing FDA to observe the manufacturing process for an unreasonably short amount of time.
- Requiring an FDA inspector to leave a facility before the inspection is finished
- Resisting photography that an FDA inspector feels is necessary to effectively conduct the inspection
- Refusing to allow an FDA inspector to review records that FDA has authority to inspect
- Providing unreasonably redacted records to FDA
- Refusing to allow an FDA inspector to collect samples
- Failing to answer or respond to FDA’s calls
What circumstances will FDA potentially deem reasonable?
- Delays due to local conditions, such as weather or security situations, holidays and other non-work days, and scheduled manufacturing campaigns
- Delays due to the time it takes FDA to accommodate documented gowning requirements
- Delays due to the time it takes to translate requested records into English
- Delays due to FDA requesting records that are currently being used for a manufacturing operation
- Delays due to the amount of time it takes to compile the requested records, within reason
- Appropriate personnel are not immediately available to answer an FDA inspector’s questions at the beginning of an unannounced inspection
- A facility is closed due to scheduled maintenance when FDA arrives for an unannounced inspection
- Denying access to a particular part of a facility because the inspector has not completed training required by the Occupational Safety and Health Administration
- Disallowing FDA to photograph products of which the product quality would be adversely affected by photography
Registrar Corp assists drug companies with FDA regulations. We can provide further guidance in regards to FDA facility inspections, as well as register a drug firm and list its products with FDA, review and modify drug product labels for FDA compliance, assist with detentions, and more. For questions about FDA facility inspections or other FDA drug regulations, contact Registrar Corp at 1-757-224-0177 or speak to a Regulatory Advisor 24 hours a day at https://www.registrarcorp.com/livehelp.