FDA Final Guidance: Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection

FDA has issued final guidance on Circumstances that constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection in June 2024. This is the final version of the draft guidance that was issued in December 2022 on same title.

As per US Laws and Acts a drug or device is deemed adulterated if factory or establishment where it is manufactured, packed or stored delays, denies or limits an inspection of the facility. The guidance define types of behaviours or actions with examples that FDA consider constitute to delaying, denying, or limiting inspection.

What constitutes Delaying the inspection:

For Preannounced inspections, not agreeing to a start date proposed by FDA, requesting a later start date after scheduling an inspection both without reasonable explanation and facility failing to respond to FDAs attempt to contact the facility designated person, responsible persons not available at the site or facility claims operations are under shutdown are all examples of what FDA will consider as Delaying the inspection.

Actions by facility and personnel like not allowing the FDA investigator access to any area in a facility though it is operational, leaving an investigator in a conference room without access to information or relevant personnel are all considered as causing Delays during the inspection.

Delay in providing the requested records in a timely manner also amounts to causing Delays during the inspection.

Denial of Inspection

Statements or physical actions intended to avoid inspection or mislead investigator like not allowing the FDA investigator to start the inspection, falsely claiming staff are not available, facility do not manufacture or handle the product or sending staff home all can fall under the ambit of denying the inspection.

What constitute Limiting the inspection

Discontinuation of manufacturing activities for the duration of inspection, interrupting production operations, limiting direct observation of manufacturing process or staff causing the FDA investigator to leave the premises all constitute Limiting the inspection. Impeding or resisting photography by FDA investigator and limiting access to or copying of records which FDA investigator consider necessary for the inspection, providing unreasonably redacted records including electronic records refusing to allow the FDA investigator from collecting samples are also examples of acts that constitute Limiting the inspection

Refusal to Permit Entry

Active or passive behaviour or inaction by the facility owner or personnel restricting FDA investigator from entering certain areas, not unlocking areas requested to be opened, refusal of personnel to respond to FDA when contacted are all acts which will be considered as Refusal to Permit Entry.

FDA will consider reasonable explanations for behaviour that may otherwise be considered to be delaying, denying, limiting, or refusing an inspection.

USFDA Final Guidance: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection