Federal inspectors documented layers of unidentified residue on production walls, floors, and equipment, corrosion on a product transfer line, and an employee working in open-toed sandals in front of open equipment at an Indian plant supplying active drug ingredients to United States compounding pharmacies.
The FDA has since barred every shipment from the company into the country, and the firm recalled all ingredients already in U.S. distribution. The agency took the unusual step of publishing photographs inside its warning letter, noting it did so to document gross insanitary conditions.
