Analysis of FDA FY2018 Drug GMP Warning Letters

By Barbara W. Unger

Identify new FDA inspection trends to proactively address similar situations in your company.


Topics of this report include:

  • Type of manufacture (API, dosage form, API and dosage form, compounding pharmacy/outsourcing facility), and country associated with the warning letter.
  • Particular targets of warning letters issued this year, including OTC drug products, drug product manufacturers, data integrity and contracted operations.
  • Interval between the inspection and enforcement actions, including issuance of a warning letter or import alert.