FDA 483 - SMS Pharmaceutical Limited - Unit VII - January 17, 2020

SMS Pharmaceuticals Limited, Unit-VII, an API manufacturer in Vizianagaram District, India, was cited for significant deficiencies during an FDA inspection. The inspection revealed that the quality control unit failed to adequately follow procedures for Out-of-Specification (OOS) investigations and complaint handling. Additionally, the firm's laboratory control mechanisms were found to be inadequate, particularly concerning method accuracy assessments for cleaning validation.