FDA 483 - SRI Krishna Pharmaceuticals Ltd - Unit I - September 01, 2023

Sri Krishna Pharmaceuticals Limited - UNIT-I, an API manufacturer in Hyderabad, India, was cited for numerous significant cGMP deficiencies during an FDA inspection. Issues include widespread failures in Quality Unit oversight, inadequate equipment cleaning and validation, deficient out-of-specification and complaint investigations, and an insufficient stability monitoring program. These observations indicate a systemic lack of control over critical manufacturing processes and data integrity.