FDA WARNING_LETTER - Reliance Life Sciences Private Limited - February 27, 2026

The FDA issued a warning letter to Reliance Life Sciences Private Limited following an inspection of its Navi Mumbai, India, facility from February 19 to February 27, 2026. The inspection identified significant violations of Current Good Manufacturing Practice (CGMP) regulations, leading the FDA to classify the firm"s drug products as adulterated under the Federal Food, Drug, and Cosmetic Act.

The primary violations involve systemic data integrity failures and inadequate sterile manufacturing controls. Specifically, the FDA found that laboratory staff falsified microbiology records by documenting samples that were never actually collected. Additionally, the firm failed to use proper mathematical factors when calculating microbial limits and lacked electronic safeguards to prevent the deletion or overwriting of testing data. Investigators also observed poor aseptic practices, such as operators blocking sterilized airflow, and noted that manufacturing equipment was poorly maintained, exhibiting signs of deterioration and improper cleaning using non-sterile materials.

In response to these findings, the company has recalled all sterile drug products from the U.S. market and suspended production for U.S. distribution. The facility was also placed on a federal import alert in July 2026. To remediate these issues, the FDA requires Reliance Life Sciences to engage independent third-party consultants to conduct a comprehensive audit of all manufacturing systems. The firm must also submit a global corrective and preventive action (CAPA) plan, perform a retrospective review of all testing data, and implement robust management oversight to ensure the reliability and accuracy of its records before resuming operations.