FDA 483 - Piramal Pharma Limited - February 13, 2025

An FDA inspection of Piramal Pharma Limited in Sangareddy District, Telangana, India, from February 9-13, 2025, revealed significant deficiencies in their quality systems. Observations included a lack of written procedures for quality control unit responsibilities, inadequate investigation records for out-of-specification results, and missing written procedures for equipment cleaning and maintenance. Additionally, production and process control procedures were not properly documented at the time of performance, indicating a need for improved adherence to good manufacturing practices.