Alembic Pharmaceuticals has got three observations from the USFDA for its formulation facility at Panelav, Gujarat.
“The United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals formulation facility located at Panelav from March 12-20, 2018. This was a scheduled inspection and at the end of the inspection, the USFDA issued a form 483 with 3 observations,” the company said in a regulatory filing today.
Alembic Pharmaceuticals said none of the observations are related to data integrity or repetitive in nature. “The company is preparing the response to the observations, which will be submitted to the USFDA shortly,” it added.
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.
Shares of Alembic Pharmaceuticals were trading at Rs 548 apiece in the morning trade, up 2.68 per cent, from the previous close on the BSE