Alembic Gets 5 USFDA Observations for Gujarat Plant
Alembic Pharmaceuticals received five observations from the USFDA after an inspection of its Gujarat-based manufacturing plant. The company will respond to the observations within the stipulated period.
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.
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.
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.
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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