USV Private Limited – FDA Warning Letter, Apr 17, 2026

On November 2, 2026, the U.S. Food and Drug Administration (FDA) issued a warning letter to USV Private Limited following an inspection of its manufacturing facility in Daman, India, conducted between April 7 and 17, 2026. The inspection identified serious violations of Current Good Manufacturing Practice (CGMP) regulations under the Federal Food, Drug, and Cosmetic Act, specifically regarding the production of sterile injectable drugs.

The primary issues centered on inadequate aseptic processing and sterility assurance. The FDA observed that the facility"s airflow visualization studies failed to demonstrate proper unidirectional airflow in critical ISO 5 areas, creating a high risk of contamination. Furthermore, personnel exhibited poor aseptic techniques, such as reaching over sterile equipment, and the facility’s design—including its conveyor systems—was found to obstruct clean airflow. Additionally, the company"s program for inspecting drug products for visible particles was deemed scientifically unsound, as it lacked appropriate alert limits and failed to classify different types of contamination.

In response to these findings, the FDA requires USV Private Limited to engage an independent consultant to conduct a comprehensive six-system audit of their operations. The company must provide detailed remediation plans, including a systematic assessment of aseptic practices, facility redesigns to address airflow hazards, and a revamped visual inspection program that aligns with updated industry standards. While the company has suspended production for the U.S. market, they must notify the FDA before resuming operations and demonstrate that all systemic flaws have been corrected to ensure product safety and quality.