FDA 483 - Sai Life Sciences Limited

Sai Life Sciences Limited, an API manufacturer in Bidar, Karnataka, India, was inspected by the FDA from June 4-8, 2018. The inspection revealed significant deficiencies across five observations, primarily concerning inadequate Out of Specification investigations, deficient cleaning validation, improper material storage, lack of controls for QA stamps, and absence of procedures for handling broken microbiological plates. These issues indicate a need for improved quality control and procedural adherence.