FDA posts photos of Indian drugmaking facility cited in warning letter

The U.S. Food and Drug Administration does not typically publish photographs alongside its warning letters. When the agency issued its latest letter to Patcos Cosmetics, a private-label contract manufacturer based in Daman, India, it included images of the facility — mold creeping across walls, water-damaged ceilings, broken windows open to the elements. The photos turn a routine enforcement document into something closer to a visual indictment, and the timing makes it hard to ignore.

Patcos manufactures over-the-counter consumer products — antibacterial hand soaps, isopropyl rubbing alcohol, oral care items — under contract for brands that sell into the U.S. market. According to the March 2026 warning letter, an FDA inspection found insanitary conditions, absent process validation, and deliberate falsification of manufacturing data. The facility had no program to test for diethylene glycol (DEG) and ethylene glycol (EG) contamination — the same toxic contaminants that killed more than 300 children globally in a wave of poisonings traced to Indian-manufactured cough syrups.

This was not a surprise inspection of an unknown operator. Patcos received a previous warning letter in December 2023 citing the same DEG and EG testing failures. The company promised corrective actions. It implemented none of them. Patcos has been on Import Alert 66-40 since November 2023, meaning its products are automatically detained at the U.S. border. An NDC labeler database_PRIVATE_LIMITED) shows the company had 11 registered products in the U.S. — all deleted by March 2024.

The warning letter itself is unusually structured. Alongside the standard citations of Current Good Manufacturing Practice violations, the FDA included a section titled "Responsibilities as a Contractor" — an explicit reminder that contract manufacturers bear the same regulatory obligations as the brands they produce for. The message is not subtle: if your CDMO cuts corners, you own the consequences.

That message lands in a very specific moment. The BIOSECURE Act, signed into law to reduce U.S. pharmaceutical dependence on Chinese contract manufacturers, is actively pushing new business toward Indian CDMOs. India is absorbing a surge of demand from Western sponsors looking for alternatives to Chinese facilities. The policy logic is sound — diversify the supply chain. The manufacturing reality is messier.

Endpoints News first reported on the unusual decision to publish facility photos alongside the warning letter, calling it a signal of stepped-up enforcement scrutiny. The enforcement data backs that up. According to PharmaSource, CDER manufacturing warning letters have tripled — from 39 in 2023 to 111 in 2025. Industry survey data from ISR Reports shows that 26 percent of pharmaceutical sponsors now cite regulatory violations as the top reason for disqualifying a contract manufacturer, making it the single most common disqualifier.

Patcos is not a major player. Its website markets it as a turnkey private-label partner for oral care products and aerosols, claiming strict quality control and cGMP compliance — claims the FDA has now twice found to be false. The company operates in Daman, a Union Territory on India's western coast known for tax incentives that attract small manufacturers. This is not Hyderabad or Bangalore, not one of the large CDMO campuses that serve Big Pharma clinical programs.

But that is precisely the point. The CDMO ecosystem does not consist solely of billion-dollar facilities with dedicated quality teams. It extends through a long tail of small contract manufacturers making the unglamorous products — the hand soaps, the rubbing alcohol, the mouthwash — that still carry FDA-regulated drug labels and still end up in American bathrooms. When the WHO issued a medical product alert-oral-liquid-medicines) about DEG-contaminated oral liquid medicines from Indian manufacturers, Patcos was not named. But its failure to test for the same contaminants puts it in the same risk category as the facilities that were.

The broader tension is structural. U.S. policy is simultaneously pushing more manufacturing toward India and tightening enforcement on the facilities that receive it. The FDA is tripling its warning letter output. It is publishing photographs of moldy walls. It is naming contractor responsibilities in language that reads less like regulatory guidance and more like a liability warning to every Western brand sourcing from the region. None of this means Indian CDMOs are categorically unreliable — some of the world's best contract manufacturers operate there. It means the quality gap between the top of the market and the long tail is wide, and getting wider, at precisely the moment when the long tail is absorbing the most new business.

For the companies choosing CDMO partners right now — and the BIOSECURE Act means many of them are choosing right now — Patcos is not the risk. Patcos is the example that makes the risk legible. A facility with mold on its walls, data in its logbooks that someone deliberately altered, and a two-year paper trail of promises it never kept. The FDA, for once, brought the receipts.