Problems We Solve: Facility Inspections

FDA inspects facilities for one of two reasons: either (1) your facility or product has been flagged as potentially bad, or (2) your number came up in the FDA inspection lottery.  These inspections can last for days or weeks, cost much more than you might think, and be extremely stressful.  We work with clients during all phases of the inspection process.  We help our clients prepare their facilities for inspections by analyzing and correcting the gaps in their processes, and we help them prepare themselves by understanding the limits of FDA’s authorities to inspect and request documents.  We also routinely work with our clients to evaluate and respond to the result of an inspection – whether a Form 483 or a Warning Letter or Untitled Letter.

Representative Experiences:

Drug Manufacturer: Responded to FDA’s issues and allegations in Untitled Letter and helped client come back into compliance.

Drug Manufacturer: Argued for FDA to issue results after several months of delaying.

Seafood Processor: Analyzed and responded to Warning Letter.

Food Manufacturer: Convinced FDA to inspect facility as a food facility rather than a drug facility.

Food Company Office: Persuaded FDA to cancel inspection of corporate office, arguing that it would be irrelevant.

Seafood Processor: Convinced FDA to prioritize a foreign facility inspection so that the firm could be placed onto a green list for an Import Alert.