FDA 483 - SNJ Labs Pvt. Ltd. - February 06, 2026

SNJ Labs Private Ltd. in Rajkot, India, an API manufacturer, was cited for significant quality control and facility maintenance deficiencies during an FDA inspection. Observations included inadequate investigation of OOS results, lack of validated test procedures, poor data integrity controls for computerized systems, and unsanitary manufacturing environments. These issues indicate a severe lack of adherence to good manufacturing practices.