Alembic Pharmaceuticals Ltd. said on Tuesday the U.S. health regulator had issued Form 483 with four procedural observations after inspection of its oncology injectable formulation facility at Panelav in Gujarat.
As per the U.S. Food and Drug Administration (U.S. FDA), Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator observes any conditions that may constitute violation of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The U.S. FDA had conducted an inspection at the facility located at Panelav from October 4, 2022, to October 14, 2022, Alembic Pharmaceuticals said in a regulatory filing.
“The U.S. FDA issued a Form 483 with four procedural observations. None of the observations is related to data integrity, and management believes that they are addressable,” it added.
The company further said it is preparing the response to the observations, which will be submitted to the U.S. FDA within the stipulated period.
