USFDA Issues Form 483 to Ipca Tarapur Plant

New Delhi, Dec 5 (PTI) Ipca Laboratories on Friday said the US health regulator has issued a Form 483 with three observations after inspecting its Maharashtra-based API plant.

The US Food and Drug Administration (USFDA) conducted the inspection of the active pharmaceutical ingredients (APIs) manufacturing facility at Tarapur (Maharashtra) from December 1-5, 2025.

At the conclusion of the inspection, the USFDA issued a Form 483 with three observations, the drug firm said in a regulatory filing.


The company will submit its comprehensive response on these observations to the USFDA within the stipulated time and will work closely with the agency to resolve these issues at the earliest, it added.

As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food, Drug and Cosmetic (FD&C) Act and related Acts.

Ipca shares were trading 0.19 per cent down at Rs 1,454.35 apiece on BSE in mid-session deals.