FDA Issues Warning Letter to Patcos Cosmetics

The United States Food and Drug Administration (FDA) issues a warning letter to Patcos Cosmetics of India for violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The company specializes in private label oral care and aerosol products.

The FDA conducted an unannounced inspection of the drug manufacturing facility, Patcos Cosmetics Pvt. Ltd., FEI 3009250196, at Survey No. 659, A Kevdi Falia Road, Daman, Dadra and Nagar Haveli and Daman, India, from July 14-18, 2025.

According to the letter, the products are adulterated under section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(A), in that they have been prepared, packed or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health.

This warning letter also summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals; in reference to Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).

During the inspection, investigators observed specific violations including, but not limited to, the following: insanitary conditions.

The FDA is requesting a comprehensive plan to remediate the facility. It also placed all drugs and drug products offered for import into the United States from the firm on Import Alert 66-40 on Nov. 17, 2023, and issued an FDA Warning Letter on Dec. 15, 2023, after review of a response to a 704(a)(4) Request for Records sent on July 12, 2023.

The findings detailed above further demonstrate the firm’s “noncompliance, regardless of affirmed compliance to CGMP and inspectional readiness status,” said the FDA.

The firm remains on Import Alert 66-40.

Read the full letter here.

Looking for more FDA warning letters? Subscribe to Happi’s newsletter to learn more!