FDA 483 - Recipharm Pharmaservices Private Limited - February 13, 2020

An FDA inspection of Recipharm Pharmaservices Private Limited, a drug manufacturer in Bangalore, Karnataka, India, revealed significant deficiencies in equipment management and electronic recordkeeping. The firm failed to perform routine inspections of automatic, mechanical, and electronic equipment according to a written program, and electronic records lacked proper retention, system access limitations, and audit trails. These issues compromise the trustworthiness and reliability of critical data, indicating serious quality control and data integrity concerns.