US FDA makes five observations after Alembic Pharma facility inspection

The United States Food and Drug Administration (USFDA) conducted an inspection at Alembic Pharmaceuticals New Injectable Facility (F-3) at Karkhadi from January 29, 2021 to February 5, 2021. “This was a scheduled inspection and at the end of the inspection, the USFDA issued a Form 483 with five observations,” informed a company statement.

A Form 483 is issued to a company after concluding 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.

Alembic Pharma informed that “none of the observations are related to data integrity and are procedural in nature.”

“The company is preparing the response to the observations, which will be submitted to USFDA shortly,” it said.