IPCA Ratlam (India) issued USFDA 483 with 11 observations after inspection in June 2023 by USDA inspectors Rajiv srivastava, Salim Akhtar, Wenzheng Zhang. The observations cites deficiencies in the manufacture and control of APIs and Intermediates – failure in investigations of OOS, Deviation, Complaints; failure in establishing adequate manufacturing controls and parameters, cleaning verification, carry over impurities; Inadequacies in test methods and laboratory tests, deficiencies in chromatographic integration, pH meter calibration, secondary standard certification; failure of Quality unit in reporting deviations in batch certificates by third party consultants, maintaining complete records of equipment usage Read More
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