The US health regulator had conducted an inspection at Alembic Pharmaceuticals, Panvel plant and has not issued any observations.
In a BSE filing the company stated, “The United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals API Facility located at Panelav from April 16-23, 2018. This was a scheduled inspection and at the end of the inspection, there were zero 483s.”
Further, the Form 483 is issued to a firm’s management at the conclusion of an inspection, when an investigator notices any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic Act and related acts and it notifies the company’s management of objectionable conditions at a facility.
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