FDA 483 - Sri Krishna Pharmaceuticals Limited - Unit IV - April 11, 2025

Sri Krishna Pharmaceuticals Limited, an API manufacturer in Sangareddy, Telangana, received a Form 483 with three observations. The inspection revealed significant deficiencies in the firm's quality system, including inadequate investigations into discrepancies, a deficient quality control unit with poor data integrity practices, and unsuitable manufacturing equipment. These issues indicate a lack of robust controls over critical manufacturing and quality processes.