FDA halts US shipments from Shoolin Pharma after unsanitary inspection findings
read at STAT ↗RegulatoryNegative
The Food and Drug Administration issued a warning letter to Shoolin Pharma after an April inspection uncovered unsanitary conditions at its Gujarat facility.
The letter cited residue and stains on walls, floors and equipment, corrosion on a product line, an employee wearing open-toed sandals, and incomplete laboratory testing records.
Following the findings, the FDA ordered a stop to all shipments of the company's active pharmaceutical ingredients to the United States.
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This writeup was produced by pharmadog from original reporting by STAT.
Original headline: “STAT+: FDA warns an API supplier about residue on walls, a corroded product line, and open-toed sandals”
read at STAT ↗512 words · retrieved Sep 8
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