483
Cosmaceutical Research Lab Inc.FDA 483 - Cosmaceutical Research Lab Inc. - June 10, 2022
Record Details
An FDA inspection of Cosmaceutical Research Lab Inc. in Surrey, a drug manufacturer, revealed significant deficiencies in laboratory controls, investigation procedures, and quality control unit responsibilities. The firm failed to establish adequate microbiological testing methods, properly investigate out-of-specification events and product failures, and maintain appropriate quality control practices including data integrity and equipment cleanliness. These observations indicate a lack of robust quality systems for their OTC drug products.
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ID · 98743c4c-1157-41b6-8033-0db4bca5c010