USFDA determines inspection classification of VAI for the contract manufacturing facility at Spokane, Washington
Jubilant HollisterStier is a subsidiary of Jubilant Pharma Holding
Jubilant HollisterStier is a subsidiary of Jubilant Pharma Holding
Investment in new plant meets increasing demand for functional excipients for oral drug delivery
The recent inspection covered both cGMP and PAI processes
The company will take all necessary steps to work with USFDA towards earliest remediation of the above facility
USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation
The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
The inspection was concluded with two 483 observations
The inspection closed with five observations which were more of procedural changes with none of these related to data integrity
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