USFDA inspects Alembic Pharma’s facility in Karkhadi
The US health regulator issued a form 483 with two observations
Drug firm Alembic Pharmaceuticals said the US health regulator has conducted an inspection at its facility in Karkhadi, Gujarat. At the end of the inspection, the United States Food and Drug Administration (USFDA) issued a form 483 with two observations, the drug firm said in a filing to BSE.
“The US Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals active pharmaceutical ingredient (API) facility located at Karkhadi from January 13 to January 17, 2020,” it said. This was a scheduled pre-approval inspection.
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