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.
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.
