Alembic Pharma Gujarat facility gets 5 USFDA observations
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.
As per the USFDA, a Form 483 is issued to a firm''s management at the conclusion of an inspection when an investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. It notifies the company''s management of objectionable conditions.
Alembic Pharma said none of the observations were related to data integrity and were procedural in nature.
"The company is preparing the response to the observations, which will be submitted to USFDA shortly," the company said.