FDA 483 - Cosmetic Essence, Inc. - December 06, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 6a994aef-a609-4676-9b16-58c77e23ea84