FDA 483 - Piramal Pharma Limited - February 17, 2025

Piramal Pharma Limited, an API manufacturer in Navi Mumbai, India, received an FDA Form 483 citing multiple significant deficiencies during an inspection. Observations included inadequate quality control unit procedures, insufficient investigation follow-up for API deviations and customer complaints, unvalidated cleaning procedures for shared equipment, incomplete master production records, and improper handling and storage of key starting materials and APIs leading to contamination. These issues indicate a lack of robust quality systems and controls over critical manufacturing processes.