STAT+: FDA warns an API supplier about residue on walls, a corroded product line, and open-toed sandals
The FDA warned a supplier of active pharma ingredients about residue on walls, a corroded product line, and open-toed sandals at its facility. It also included photos.
STAT PlusPharmalot FDA warns an API supplier about residue on walls, a corroded product line, and open-toed sandals The agency made a point of including photos of the unsanitary conditions in a letter to the company Manage alerts for this article Email this article Share this article By Ed SilvermanSept. 8, 2026 Pharmalot Columnist, Senior Writer Ed Silverman[email protected]Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning Pharmalittle newsletter and the afternoon Pharmalot newsletter.
Residue and stains plastered on production walls, floors, and manufacturing equipment. Corrosion on a product line. An employee wearing open-toed sandals.
These were among the unsanitary conditions found last April by a Food and Drug Administration inspector during a visit to Shoolin Pharma in Gujarat, India, where the company makes active pharmaceutical ingredients for more than a dozen medicines, including erectile dysfunction and anti-convulsant pills, that are sold to compounding pharmacies in the U.S., according to the agency.Advertisement The concerns about filth and possible contamination in the production and packaging areas — as well as incomplete laboratory testing records — prompted the agency last month to halt all product shipments by the company into the U.S., the FDA disclosed in an Aug. 18 warning letter that was posted on the FDA web site last week. STAT+ Exclusive Story Already have an account?
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