483
Cosmetic Essence, Inc.Cosmetic Essence, Inc. – FDA 483, Dec 6, 2024
Record Details
Cosmetic Essence, Inc. in Ridgefield, NJ, an OTC drug manufacturer, was inspected by the FDA from December 4-6, 2024. The inspection revealed significant issues related to equipment cleaning validation for non-dedicated equipment used in OTC drug and cosmetic product manufacturing. Additionally, the firm failed to thoroughly review unexplained discrepancies and out-of-specification (OOS) results, invalidating initial OOS results without re-testing original samples or documenting reasons.
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ID · 6a994aef-a609-4676-9b16-58c77e23ea84
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