Vimal Patel
Patcos Cosmetics Pvt. Ltd.
120, Mahavir Industrial Estate
Mahakali Caves Rd
Mumbai 400093
Maharashtra
India
vpatel@patcoscosmetics.comFEI 3009250196Issued Dec 15, 2023Center for Drug Evaluation and Research | CDER
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3009250196.
Patcos Cosmetics Pvt. Ltd., an over-the-counter drug manufacturer in India, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated. The company failed to conduct required identity testing on incoming components at high risk of contamination with diethylene glycol (DEG) or ethylene glycol (EG), specifically for glycerin, propylene glycol, and sorbitol solution used in drug manufacturing. This violation of 21 CFR 211.84(d)(1) was identified during FDA's review of records submitted in response to a July 2023 information request.
Patcos Cosmetics Pvt. Ltd. FDA Warning Letter, December 15, 2023
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