Lupin has received a warning letter from the USFDA for their Tarapur, Maharashtra facility. The U.S. FDA had inspected the Lupin Tarapur site from March 22, 2022 to April 4, 2022.
Initially, USFDA has closed the inspection at Lupin’s Tarapur manufacturing facility with four observations.
Tarapur facility was placed under USFDA OAI status from January,2020 after it received three observations during USFDA inspection in September,2019. Tarapur is a fermentation and chemical synthesis based multi-product API manufacturing facility, although management indicated at Nagpur facility procuring newer APIs from Vizag facility and older ones from Tarapur and Dabhasa facility.
Lupin said that the company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility.
Lupin said in a press release, "We are committed to addressing the concerns raised by the U.S. FDA and will work with the U.S. FDA to resolve these issues at the earliest. We uphold quality and compliance issues with utmost importance and remain committed to be compliant with CGMP quality standards across all our facilities."