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Alembic Pharma receives four observations from USFDA for Panelav facility

"The US Food and Drug Administration (USFDA) had conducted an inspection at Alembic Pharmaceuticals general oral solid formulation facility located at Panelav from 9-13 March, 2020," the drug firm said in a filing to the BSE

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Alembic Pharmaceuticals has recently said that the US health regulator has conducted an inspection at its Panelav facility in Gujarat and issued Form 483 with four procedural observations.

“The US Food and Drug Administration (USFDA) had conducted an inspection at Alembic Pharmaceuticals general oral solid formulation facility located at Panelav from 9-13 March, 2020,” the drug firm said in a filing to the BSE.

This was a scheduled inspection, and at the end of the inspection, the USFDA issued a Form 483 with four procedural observations.

None of the observations are related to data integrity or are repetitive in nature.

“The company will provide comprehensive corrective action report to address each observation. The company is committed to maintaining highest quality standards that meet USFDA standards,” it said.

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