USFDA issues Form-483 with 8 observations to Lupin’s drug, API production facilities in Mandideep plant

The USFDA had inspected the Mandideep Unit-1 facility in Madhya Pradesh from November 14, 2022, to November 23, 2022, the Mumbai-based drug maker said in a regulatory filing. “The inspection of the facility closed with issuance of a Form-483 with eight observations each for the drug product facility and active pharmaceutical ingredient (API) facility at the site,” it added.