FDA WARNING_LETTER - SHOOLIN PHARMA CHEM LLP - April 17, 2026

The FDA issued a Warning Letter to Shoolin Pharma Chem LLP following an inspection from April 13 to 17, 2026, at its facility in Gujarat, India. The inspection revealed that the company’s active pharmaceutical ingredients (APIs), including sildenafil citrate and tadalafil, were manufactured under gross insanitary conditions and violated Current Good Manufacturing Practice (CGMP) standards. Consequently, these products are considered adulterated under the Federal Food, Drug, and Cosmetic Act.

Main violations included pervasive filth, such as unidentified layered residues on manufacturing equipment, leaking production lines, and corroded surfaces near open processing areas. Investigators also observed employees wearing improper footwear in production zones and a significant lack of cleaning procedures for shared equipment, posing a high risk of cross-contamination. Furthermore, the firm failed to maintain complete laboratory records, lacked a functional stability testing program to support product shelf-life, and demonstrated a total failure of the quality unit to oversee manufacturing and testing operations.

In response to these findings, the firm initiated a voluntary recall of all APIs distributed in the U.S. and was placed on an import alert on August 11, 2026. The FDA requires Shoolin Pharma Chem to hire a qualified independent consultant to conduct a comprehensive audit of their operations. Required actions include submitting a facility remediation plan, performing a retrospective assessment of cleaning effectiveness and data integrity, and providing evidence that the quality unit has been granted the authority to ensure product safety and purity. The company must respond within 15 business days outlining its corrective measures.