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 above story is verified and authored by Press Trust of India (PTI) staff. PTI, India’s premier news agency, employs more than 400 journalists and 500 stringers to cover almost every district and small town in India.. The views appearing in the above post do not reflect the opinions of LatestLY)













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