The U.S. FDA hit India-based Lupin Pharmaceuticals with a Form 483, issuing four observations after inspecting its API plant in Tarapur.
Following an inspection that took place between March 22 and April 4, the agency noted that existing procedures and processes for manufacturing APIs were inadequate and the facility had failed to establish and validate its cleaning process.
The facility also failed to properly create process sampling and control conditions, according to the agency’s observations. Back in January 2020, the same Tarapur plant was issued an Official Action Indicated (OAI) status by the FDA, meaning that recommendations for certain regulatory actions were likely incoming.
Lupin's issues are not exclusive to its India plants either. In June 2021, the FDA issued a warning letter to Lupin for a number of quality-related failures at the company’s Novel Laboratories factory in New Jersey. In its conclusion, the FDA warning chided Lupin for repeated cGMP violations and pointed to warning letters issued to the company in 2017 and 2019. The agency threatened to withhold the company’s Export Certificates and approval for new applications if Lupin failed to address the violations.