India’s Patcos Markets Insanitary OTC Drugs with CGMP Issues: FDA

An unannounced 7/14-7/18/2025 FDA inspection at the Patcos Cosmetics Pvt. Ltd. drug manufacturing facility in Dadra and Hagar Haveli and Daman, India, found adulterated over-the-counter drug products that have been prepared, packed, or held under insanitary conditions, and had significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/12 Warning Letter includes photographs of some of the insanitary conditions the FDA staff found. Patcos was told to provide a comprehensive plan to remediate the facility, given the nature of the insanitary conditions, and detailed procedures demonstrating that the firm can maintain buildings free from pests and that they remain in a clean and sanitary state.

The letter also lists these CGMP violations:

• failure to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair;
• failure to conduct at least one test to verify the identity of each component of a drug product;
• failure to establish adequate written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess; and
• failure to establish an adequate quality unit, and failure to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit.

FDA reminds Patcos that it is responsible for the quality of the drugs it produces as a contractor, regardless of agreements in place with product owners. It strongly recommends that it engage a qualified third-party consultant to evaluate its operations and assist it in meeting CGMP requirements.

Patcos’ products were placed on an 11/17/2023 Import Alert and remain subject to that Alert, FDA says. It notes that in response to an FDA 12/15/2023 Warning Letter, the company elected to re-register its facility, stating its readiness for inspection and emphasizing its ongoing compliance with CGMP and “adhering to the highest quality standards.”

The letter says the current inspection findings “further demonstrate your firm’s noncompliance, regardless of your affirmed compliance with CGMP and inspectional readiness status.”

Patcos was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.