FDA halts imports of Shoolin Pharma products to the US after inspection in India
The US Food and Drug Administration (FDA) has halted imports into the United States of all products from Indian company Shoolin Pharma after finding unsanitary conditions at its facility in Gujarat state. The company produces active pharmaceutical ingredients for more than a dozen drugs, including medicines for erectile dysfunction and anticonvulsants.
Inspection observations
An FDA inspector visited the Shoolin Pharma facility in April. According to STAT News, the agency documented residue and stains on walls, floors, and production equipment, as well as corrosion on one of the production lines. One employee was wearing open-toed footwear.
The FDA also raised concerns about possible contamination in production and packaging areas. Separately, the regulator noted incomplete records of laboratory testing.
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Supply restrictions
In August, the FDA halted all shipments of Shoolin Pharma products to the United States. The agency reported this in a warning letter dated August 18, which was later published on the FDA website. The letter also included photographs of conditions the regulator described as unsanitary.
Shoolin Pharma's active pharmaceutical ingredients were sold to US pharmacies that prepare medicines to order.
