FDA 483 - Cronus Pharma Specialities India Pvt Ltd - August 20, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 29622c0b-f177-4aae-b285-cfafed1af44f