FDA 483 - Cronus Pharma Specialities India Pvt Ltd - August 20, 2025

An FDA inspection of Cronus Pharma Specialities India Pvt Ltd in Hyderabad revealed significant deficiencies in their manufacturing of large volume parenteral drug products. Observations included poor facility maintenance with contamination risks, inadequate written procedures for contamination control, and failures in quality control unit responsibilities, including product complaint handling and media fill documentation. Additionally, the firm lacked proper controls for manufacturing process validation, visual inspection operator qualification, and computer system access, indicating a broad range of GMP non-compliance.