FDA blocks U.S. shipments from Indian API maker after unsanitary inspection
The FDA has suspended all U.S. shipments from Shoolin Pharma in Gujarat after an inspection uncovered filth, corrosion and safety lapses.
An FDA inspector visited Shoolin Pharma, which produces active pharmaceutical ingredients for dozens of U.S. compounding drugs, and found residue on walls, corroded equipment and an employee in open-toed sandals. The agency also noted incomplete laboratory testing records. As a result, the FDA issued a warning letter and halted all product exports to the United States.
Why it matters
U.S. patients could receive unsafe medicines if contaminated ingredients enter the supply chain.
In this story
FDAinspectionunsanitary conditionsshipment haltactive pharmaceutical ingredientscompounding pharmaciesGujaratcorrosionopen-toed sandals
