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US FDA completes Alembic Pharma’s Panelav plant with zero 483s

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The company’s formulation facility at Panelav had received three form 483 observations in March 2018.

US FDA has completed an inspection at Alembic Pharmaceuticals’ Panelav facility and has not made any observations, reports the company.

“The Food and Drug Administration (US FDA) 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,” Alembic Pharmaceuticals said.

The company’s formulation facility at Panelav had received three form 483 observations in March 2018.

An FDA Form 483 is issued at the end of an inspection if the investigator(s) observe any factors that may comprise violations of the Food Drug and Cosmetic Act and related acts.

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