By CNBCTV18.com Apr 18, 2022 11:52:48 AM IST (Updated)
Lupin's Tarapur plant was inspected from March 22 to April 4 and it was concluded that the existing procedures and processes for manufacturing APIs were inadequate.
The US Food and Drug Administration (US FDA) has issued Form 483 to Lupin’s Tarapur Active Pharmaceutical Ingredient (API) plant with four observations.
A Form 483 is issued by US FDA to a company after an inspection if the investigation concludes with any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Lupin's Tarapur plant was inspected from March 22 to April 4 and it was concluded that the existing procedures and processes for manufacturing APIs were inadequate.