Alembic Pharmaceuticals Gujarat facility recieves observations from USFDA

Alembic Pharmaceuticals said the US health regulator has issued Form 483 with two observations for its injectable facility at Karkhadi in Gujarat, following an inspection. As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management after an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

The US Food and Drug Administration (USFDA) inspected the injectable facility (F-3) at Karkhadi from August 18, 2022, to August 30, 2022, Alembic Pharmaceuticals said in a regulatory filing. The firm further said the USFDA issued a Form 483 with two observations but none of the observations is related to data integrity and the "management believes that they are addressable". Alembic said it is preparing the response to the observations, which will be submitted to the USFDA within the stipulated period.