FDA 483 - Hetero Labs Limited - September 08, 2023

An FDA inspection of Hetero Labs Ltd. Unit 1, an API manufacturer in Jinnaram Mandal, India, revealed significant deficiencies. Observations included non-contemporaneous laboratory data documentation and inadequate cleaning validation studies that failed to consider worst-case conditions. Furthermore, the firm's laboratory controls were found to be insufficient for ensuring conformance to specifications, and complaint investigations lacked thorough root cause analysis and comprehensive impact assessments.