Shilpa Pharma Lifesciences’ Unit II, Raichur, Karnataka clears PMDA Japan, GMP inspection
The inspection has concluded successfully on 1st September 2023 without any critical/major observation
The inspection has concluded successfully on 1st September 2023 without any critical/major observation
The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.
The inspection was conducted at its Goa, Vema manufacturing facility
The inspection was conducted at Granules Pharmaceuticals Inc. (GPI) from July 31, 2023 to August 03, 2023
The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
The inspection closed with zero observations
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
This is the second US FDA GMP inspection of this facility within one year
The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin’s marketed products worldwide
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