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The US health regulator has issued 3 observations to Alembic Pharmaceuticals Ltd, after inspecting its formulation facility in Panelav, Gujarat.
In a regulatory filing the company said, “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.
Further the company stated that, none of the observations are related to data integrity or repetitive in nature and the company is preparing the response to the observations, which will be submitted to the USFDA shortly.
