FDA WARNING_LETTER - SHIMOGA CHEMICALS - January 23, 2026

The FDA issued a warning letter to Shimoga Chemicals following an inspection of its manufacturing facility in Maharashtra, India, from January 19 to 23, 2026. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) standards for active pharmaceutical ingredients (APIs), specifically clomiphene citrate USP. These failures render the products adulterated under the Federal Food, Drug, and Cosmetic Act.

Main violations identified include critical data integrity failures, such as the omission of unfavorable test results from batch records and a lack of oversight for electronic analytical data. The company also failed to establish scientifically sound sampling procedures or verify its testing methods, meaning there is no assurance of the quality and purity of the distributed drugs. Furthermore, the firm lacked adequate manufacturing process validation and robust cleaning protocols for shared equipment, increasing the risk of cross-contamination. The Quality Unit was found to be ineffective, failing to investigate discrepancies, maintain complete stability records, or provide necessary training to personnel.

In response to these findings, Shimoga Chemicals initiated a voluntary product recall in May 2026, and the FDA placed the firm on an import alert in June 2026. The FDA requires the company to provide a comprehensive remediation plan, including a retrospective data integrity investigation and an independent assessment of laboratory operations. The agency also strongly recommends hiring a qualified consultant to perform a full system audit and assist in bringing the facility into compliance. A detailed response addressing these issues must be submitted within 15 working days.