Patheon Manufacturing Services LLCFebruary 23, 2024

FDA 483 - Patheon Manufacturing Services LLC - February 23, 2024

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Record Details

An FDA inspection of Patheon Manufacturing Services LLC, a contract drug manufacturer in Greenville, NC, identified one observation related to laboratory control mechanisms. The firm failed to properly label settle plates used for environmental monitoring during final drug product sterility release testing, specifically lacking expiration dates. This indicates a deficiency in following established laboratory control procedures.

Company: Patheon Manufacturing Services LLC
Inspection Date: February 23, 2024
Product Type: Drugs
Office: Atlanta District Office
People: Laurel A. Beer
Shafiq S. Ahadi (Investigator)

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ID · 9361c433-63b1-4a97-b5fe-1d18c38a1ade