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

Hetero Lab Limited Unit IX, an API manufacturer in Nakkapally, India, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm was cited for inadequate investigations into impurity contamination, poorly established and validated cleaning processes for non-dedicated equipment, and reprocessing of materials using unvalidated manufacturing processes. These issues highlight a lack of robust quality control and process validation.