The FDA has banned shipments from an Indian API supplier after inspectors discovered unsanitary conditions, including residue on equipment and improper employee attire.

The Food and Drug Administration has issued a warning letter to Shoolin Pharma, an active pharmaceutical ingredient manufacturer based in Gujarat, India, prohibiting the company from shipping products into the United States. The agency's decision follows an April inspection that uncovered significant sanitary failures at the facility, which produces ingredients for various medications, including anti-convulsant and erectile dysfunction drugs.

Inspection Findings and Safety Concerns

During the April visit, FDA inspectors documented residue and stains on production floors, walls, and manufacturing equipment. The report also noted corrosion on a product line and observed an employee wearing open-toed sandals in the facility. Beyond these sanitary issues, the agency cited incomplete laboratory testing records as a primary concern for the safety of products intended for U.S. compounding pharmacies.

Regulatory Action

The FDA formally disclosed the import ban in an August 18 warning letter, which was subsequently published on the agency's website. The directive mandates a complete halt to all product shipments from the Gujarat site into the U.S. market until the identified contamination and record-keeping deficiencies are resolved.