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.