US FDA issues three observations after Alembi's Panelav formulations facility
21 Mar 2018
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Alembic Pharmaceuticals Ltd on Wednesday said that the US health regulator inspected its formulation facility at Panelav in Gujarat and made three observations, none of which are related to dat integrity or repetitive in nature.
“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.
It added, “The company is preparing the response to the observations, which will be submitted to the USFDA shortly,” it added.
The USFDA issues a Form 483 at the conclusion of an inspection when its investigators observe any conditions that in its judgement may violate the Food Drug and Cosmetic (FD&C) Act and related Acts.
Alembic has formulations facilities at Vadodara, Panelav and Baddi.
