USFDA issues Form 483 with 3 observations to Ipca’s Tarapur plant

USFDA issues Form 483 with 3 observations to Ipca’s Tarapur plant

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…

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