Latest News | Alembic Gets 5 Observations from USFDA for Gujarat-based Plant

New Delhi, Nov 23 (PTI) Alembic Pharmaceuticals on Saturday said the US health regulator has issued Form 483 with five observations after inspecting its Gujarat-based manufacturing plant.

The US Food and Drug Administration (USFDA) conducted inspection at Jarod-based solid oral formulation facility from November 14-22, 2024, the drug firm said in a regulatory filing.

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The USFDA issued a Form 483 with five procedural observations, it added.

The company will provide a comprehensive response to the USFDA for the observations within the stipulated period, it said.

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