FDA Publishes Warning Letter with Photos of Insanitary Conditions at Patcos Cosmetics

The USFDA has issued a Warning Letter to the Indian drug manufacturing facility of Patcos Cosmetics Pvt. Ltd. in Daman (March 2026). In a rare move, the FDA also published photographic evidence of insanitary conditions observed during inspection.

USFDA investigators Tamil Arasu and Paranthaman Senthamaraikannan conducted an unannounced inspection at the facility between July 14–18, 2025. The inspection revealed gross cGMP violations, including dilapidated facilities, inadequate testing, lack of process validation, and insanitary manufacturing practices. The firm manufactures OTC drug products that were prepared, packed, and held under conditions unfit for pharmaceutical production.

Insanitary conditions

Production operations (including filling lines) are conducted in a facility that lacked adequate separation from the external environment with broken windows, insanitary production area sinks, harborage areas (potential pest/pathogen sites), and significant water damage. The facility’s conditions did not provide adequate protection for manufacturing operations from potential contamination with filth

 cGMP Violations

1. Facility in disrepair / 21 CFR 211.58

The facility is not maintained in a good state of repair with findings of dirt residue, water damage, brown discoloration and green mold-like growth across ceilings and walls in several areas, including production and storage areas. This is a repeat observation from a 2017 inspection, indicating lack of proper remediation and maintenance.

2. Inadequate identity testing / 21 CFR 211.84(d)(1)

The Firm repeatedly failed to conduct adequate identity testing of high-risk components. Firm used Indian Pharmacopeia (IP) specifications which did not require impurity testing or identity testing for some components, sampling procedures were not adequately documented or representative of each shipment / lot of components, and used unvalidated and unverified methods for identity testing.

3. Inadequate Process Controls & Validation / 21 CFR 211.100

The Firm failed to validate production process for component used in manufacture of the drug products; the system had several design flaws (ball valves, tubing with numerous joints, inadequate pipe sloping, threaded fittings and usage of tape). The system was not adequately maintained or periodically sanitized. Also the manufacturing processes for the drug products were not validated. At least eight batches of drug product were found to be super potent for the active ingredient.

4. Inadequate Quality Unit / 21 CFR 211.22(a) and (d)

The Quality unit (QU) was ineffective to oversee the quality of drug manufacturing operations including laboratory data control, deliberate alteration of original data to conceal out-of-specification results, batch production and control records, specifications, sampling plans, test methods, and stability programme. The QU was not enabled to exercise proper authority and insufficiently implemented its responsibilities.

History of Warning Letters, Import Alert

The Firm was issued a Warning letter in December 2023 after responses were found inadequate following FDA’s704(a)(4) Request for Records. Facility was placed on Import Alert 66-40 in November 2023. Further the Firm elected to re-register the facility stating readiness for inspection and ongoing compliance with cGMPs, adhering to highest quality standards. The Firm is currently not producing drug products for the United States (U.S) markets, however the processing lines were previously used for products for the US and the Firm continue to supply products to other markets.

Learnings

Drug Manufacturing operations and controls should comply with basic cGMPs to ensure quality, integrity and safety of drug products irrespective of the markets being supplied. Drug Manufacturing Firms registered with USFDA must ensure compliance with requirements of CGMP regulations 21 CFR parts 210 and 211. Non-compliance lead to regulatory actions like Warning letter and Import alert and FDA action of publishing of photo evidence of cGMP non compliances has significant reputational risk to companies.

USFDA Warning Letter Patcos Cosmetics (2026)