FDA 483 - NATCO Pharma Limited - October 18, 2023

NATCO Pharma Limited, an Indian manufacturer of sterile and non-sterile drug products, was cited for significant deficiencies during an FDA inspection. Observations included inadequate cleaning and maintenance of equipment leading to potential cross-contamination, and a lack of proper quality control unit oversight regarding GMP documentation and data integrity. The firm also failed to establish adequate procedures to prevent microbiological contamination in sterile drug products and had deficiencies in OOS investigations and computer system controls.