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.
The FDA has issued a warning to Shoolin Pharma, a supplier of active pharmaceutical ingredients, due to unsanitary conditions at their production facility in Gujarat, India. During an inspection in April, inspectors found residue and stains on production walls, floors, and equipment, corrosion on a product line, and an employee wearing open-toed sandals.
These conditions, along with incomplete laboratory testing records, led the FDA to halt all product shipments from the company to the U.S. The warning letter, posted on the FDA website last week, follows a series of concerns over potential contamination in the production and packaging areas.
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