483
COSMETIC LABORATORY INCCOSMETIC LABORATORY INC – FDA 483, Aug 3, 2022
Record Details
Cosmetic Lab, Inc. in Downey, CA, a contract manufacturer, was cited for significant deficiencies in its quality control and manufacturing processes for OTC drug products like hand sanitizer and SPF. The inspection revealed issues with component identity testing, lack of process and equipment validation, inadequate cleaning validation, and insufficient vendor qualification. Additionally, annual product reviews lacked necessary detail for quality evaluation.
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ID · 0cd75eb5-4254-4464-bbfc-0ae76c6aa504
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