FDA 483 - Hetero Labs Ltd. - Unit IX - May 14, 2019

Hetero Lab Limited Unit IX, an API manufacturer in Nakkapally, India, was cited for significant deficiencies during an FDA inspection. Observations included inadequate investigations into impurity contamination and risk evaluation, unvalidated cleaning processes for non-dedicated equipment, and reprocessing of materials using unvalidated methods without stability data. These issues indicate a lack of robust quality control and process validation.