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.
Lupin has been under the regulatory lens recently with the company's Tarapur plant receiving a warning letter last month for an inspection conducted between March and April this year. The unit had received an Official Action Initiated (OAI) status in January 2020, followed by four observations on reinspection in April this year.
