FDA 483 - Cronus Pharma Specialities India Pvt Ltd - August 29, 2023

An FDA inspection of Cronus Pharma Specialities India Pvt Ltd in Hyderabad, India, a sterile injectable veterinary drug manufacturer, revealed two significant observations. The firm was cited for inadequate controls over computer systems, including lack of performance qualification and audit trails for critical equipment, and deficiencies in its quality control unit's responsibilities, specifically regarding employee training documentation and assessment. These issues indicate a need for improved data integrity and quality system oversight.