FDA 483 - SMS Pharmaceutical Limited - Unit VII - December 12, 2025

SMS Pharmaceuticals Limited, Unit-VII, an API manufacturer, was cited for failing to ensure that specifications for Active Pharmaceutical Ingredients (API) are scientifically sound and appropriate. Specifically, the firm did not follow its established criteria for extraneous matter testing, leading to a batch with failing results being incorrectly reported as passing and subsequently dispatched to the US market.