483
Catalent Ontario LimitedFDA 483 - Catalent Ontario Limited - January 20, 2023
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An FDA inspection of Catalent Ontario Limited, a non-sterile bulk drug manufacturer in Windsor, identified one observation. The firm was cited for not storing drug product reserve samples in an immediate container-closure system that matches the marketed product. This indicates a potential issue with sample integrity and regulatory compliance.
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ID · bc9269fb-55da-4c79-9e30-2d8278f5d52e