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"FY2018 warning letters continued to focus on contracted activities, an area of focus that in my opinion will continue into the foreseeable future."
BARBARA W. UNGER

An Analysis of FDA FY2018
Drug GMP Warning Letters

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.

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