Final Guidance for Justifying Drug/Device Inspection Delays, Denials Unveiled by FDA

Parameters for slowing or blocking an FDA drug or device inspection are now available to manufacturers and storage facilities, following the agency’s release of its final guidance on the subject Friday.

“Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection,” finalizes draft guidance from December 2022 while replacing final guidance from 2014.

The guidance lists examples of delay in scheduling a pre-announced inspection that may cause drugs or devices to be adulterated, that primarily include non-response to the agency’s attempts to contact a facility, and failure to provide a reasonable explanation for not agreeing to the inspection start date.

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