FDA 483 - Sri Krishna Pharmaceuticals Limited - Unit IV - August 04, 2023

An FDA inspection of Sri Krishna Pharmaceutical LTD, an API manufacturer in Telangana, India, revealed significant deficiencies across its quality system. The firm was cited for inadequate investigations into out-of-specification results and data integrity issues, as well as failures in laboratory controls and equipment design. Further observations included insufficient cleaning validation and a deficient stability monitoring program, indicating a systemic lack of robust quality oversight and control over critical manufacturing and testing processes.