Last Updated on October 9, 2024 by The Health Master
Alembic Pharma today said the U.S. Food and Drug Administration (USFDA) has issued a Form 483 with four procedural observations after an inspection of its oncology injectable formulation facility at Panelav in Gujarat.
The USFDA conducted an inspection at the facility located at Panelav from October 4th to October 14th, 2022, Alembic Pharma said in a regulatory filing.
“The USFDA issued a Form 483 with four procedural observations.”
None of the observations is related to data integrity, and management believes that they are addressable,” it added.
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