Alembic Pharma today said the US health regulator has issued a Form 483 with four procedural observations after inspection of its oncology injectable formulation facility at Panelav in Gujarat.
The FDA had conducted an inspection at the facility located at Panelav from 4th to 14th October, 2022, Alembic Pharma said in a regulatory filing.
“The US FDA 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.
Edits by EP News Bureau