Issues Form 483 with four procedural observations
Alembic Pharmaceuticals announced that US Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals General Oral Solid Formulation Facility located at Panelav from 9 March 2020 to 13 March 2020. 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 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.
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