FDA 483 - Hetero Labs Limited - September 28, 2018

An FDA inspection of Hetero Labs Limited, an API manufacturer in Sanga Reddy District Telangana, India, revealed significant deficiencies in quality control, cleaning validation, process validation, and documentation. The firm failed to conduct thorough investigations into product contamination, adequately validate cleaning processes to remove residual contaminants, and ensure process validation protocols included critical evaluations. Additionally, contradictory documents regarding manufacturing processes were provided.