FDA 483 - Cosmetic Enterprises Ltd - June 11, 2021

Cosmetic Enterprises Ltd, a drug manufacturer in Pacoima, CA, was cited for multiple significant deficiencies across its production, quality, laboratory, and materials systems. Observations included a lack of written procedures for production controls, failure to follow reprocessing procedures, inadequate OOS investigations, and insufficient quality unit oversight. Additionally, the firm lacked appropriate computer system controls, sound laboratory specifications and sampling plans, proper laboratory record-keeping, and adequate validation of component supplier analyses.