FDA Details ‘Delaying, Denying, Limiting or Refusing’ Drug or Device Inspections

The FDA has released a draft guidance to clarify what it considers delaying, denying, limiting, or refusing a drug or device inspection.

A manufacturer’s drug or device is officially considered adulterated if, when the FDA attempts to schedule an inspection at the facility, the manufacturer doesn't agree to an inspection start date and doesn’t give a reasonable explanation, the agency explains in the 13-page draft.

A drug or device also gets the automatic label of adulterated if a facility fails to respond to the FDA’s attempts to contact the facility’s designated contact, according to the draft guidance.

Once finalized, the draft guidance, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection, will supersede the agency’s October 2014 similarly titled final guidance that focused only on drug inspections.