FDA 483 - Hetero Labs Limited - September 08, 2023
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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.
ID · 912c5b51-4aa0-4de7-a79d-557cdf487904