FDA 483 - Cronus Pharma Specialities India Pvt Ltd - January 15, 2022

This FDA Form 483 report details significant deficiencies at Cronus Pharma Specialities India Pvt Ltd concerning the manufacture of sterile and non-sterile injectable drug products. Observations highlight inadequate process and cleaning validation, failures in preventing microbiological contamination, and a lack of robust quality control unit oversight. These issues collectively pose a high risk to product quality, safety, and efficacy.