FDA 483 - Gland Pharma Limited - February 03, 2017

An FDA inspection of Gland Pharma Limited in Ranga Reddy, Hyderabad, Telangana, India, revealed significant deficiencies in aseptic processing environmental monitoring, including improper swab methods, unvalidated media, and inadequate personnel and equipment monitoring. Additionally, the firm failed to maintain backup files and time-stamped audit trails for electronic data from sterile liquid fill machines, raising concerns about data integrity. These issues indicate a lack of control over critical manufacturing processes for sterile drug products.