FDA EIR - Cosmetic Enterprises Ltd - June 11, 2021

A routine FDA cGMP surveillance inspection of Cosmetic Enterprises Ltd, a contract drug manufacturer in Pacoima, CA, was conducted from June 7-11, 2021. The inspection, performed under the Food, Drug, and Cosmetic Act and drug manufacturing regulations (e.g., 21 CFR 211.100(a), 21 CFR 211.115(a), 21 CFR 211.192, 21 CFR 211.22(d)), resulted in eight observations documented on a Form FDA 483. Key violations included the absence of adequate written procedures for production and process controls, leading to unvalidated adjustments in drug substance quantities for products like Paula’s Choice Skin Balancing SPF-30 without proper justification. The company also failed to adhere to its own reprocessing procedures, specifically by not obtaining customer approval for batch adjustments. Additionally, investigations into out-of-specification water system results for Total Organic Carbon were found to be insufficient, lacking an assessment of the potential impact on drug products. The Quality Control unit was cited for not consistently reviewing and approving critical instrument calibration records, even when an instrument failed its requirements. Other issues involved inadequate controls over computer systems, deficiencies in laboratory controls and record-keeping, and insufficient validation of component supplier analyses. Cosmetic Enterprises Ltd management acknowledged the observations and committed to submitting a written response to the Agency within 15 business days to address the identified concerns.