483
Patheon Manufacturing Services LLCPatheon Manufacturing Services LLC – FDA 483, Feb 23, 2024
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.
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ID · 9361c433-63b1-4a97-b5fe-1d18c38a1ade
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