FDA halts drug ingredient imports from Indian supplier over facility sanitation concerns

The short version

• The U.S. FDA blocked all product imports from Indian drug ingredient manufacturer Shoolin Pharma due to sanitation issues and incomplete lab records.[STAT]
• The company produces active pharmaceutical ingredients for over a dozen medications supplied to compounding pharmacies across the United States.[STAT]
• Regulators cited corrosion, stains on equipment, and an employee wearing sandals in an August warning letter posted online.[STAT]

Key facts

• The FDA halted all U.S. shipments from Shoolin Pharma over concerns regarding contamination, filth, and incomplete laboratory testing records.[STAT]
• An April inspection at Shoolin Pharma's facility in Gujarat, India, found residue on walls, equipment corrosion, and a worker wearing open-toed sandals.[STAT]
• Shoolin Pharma supplies active pharmaceutical ingredients for more than a dozen drugs to U.S. compounding pharmacies.[STAT]
• The enforcement decision was detailed in an August 18 FDA warning letter published on the agency's website.[STAT]

Sources

Outlet counts describe coverage, not independent confirmation. Reports may share a wire service or original source.

• STAT+: FDA warns an API supplier about residue on walls, a corroded product line, and open-toed sandalsSTAT metered