Lupin Biotech manufacturing facility in Pune receives 17 observations after prior approval inspection by US FDA.
The Company does not believe that the 483 letter will have an impact on the existing revenues from operations of this facility.
The U.S. FDA conducted a Prior-Approval Inspection at Lupin’s Biotech manufacturing facility in Pune, India in October 2022. The inspection concluded with the issuance of a Form 483 with seventeen observations.
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source https://www.pharmatutor.org/pharma-news/2022/lupin-gets-17-usfda-observations-for-pune-plant
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