Natco Pharma Limited – FDA 483, Aug 21, 2026

Natco Pharma Limited, a drug manufacturer in Parawada, India, was cited for significant deficiencies during an FDA inspection. Observations included inadequate air pressure controls on packaging lines leading to potential cross-contamination, deficient cleaning validation procedures, and insufficient raw material identity testing. Additionally, the firm failed to properly maintain electronic equipment and assess power supply disruptions, resulting in numerous malfunctions and data loss.