Alembic Pharma Gujarat facility gets 5 USFDA observations
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New Delhi: Alembic Pharmaceuticals on Monday said the US health regulator has made five observations after inspection at its facility at Karkhadi, Gujarat.
"The United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals'' New Injectable Facility (F-3) located at Karkhadi from January 29-February 5, 2021.
This was a scheduled inspection and at the end of the inspection, the USFDA issued a form 483 with 5 observations, the company said in a regulatory filing.
Read also: Alembic Pharma Secures USFDA Nod For Midodrine Hydrochloride Tablets
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