FDA 483 - Cosmetic Essence, Inc. - December 06, 2024

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.