FDA 483 - SMS Pharmaceuticals Limited - March 21, 2025

An FDA inspection of SMS Pharmaceuticals Limited, an API Non-Sterile Drug Substance Manufacturer in Bachupally, India, identified a significant deficiency related to employee training. The firm failed to ensure that Quality Control laboratory reviewers were adequately trained and qualified to review laboratory data for drug product release, as evidenced by specific instances involving assay and residual solvents testing.