Alembic Pharmaceuticals announced that the United States Food and Drug Administration (USFDA) has conducted PAI (Pre-Approval Inspection) at Alembic Pharmaceuticals' Solid Oral Formulation Facility (F-4) located at Jarod. The USFDA issued a Form 483 with 5 procedural observations.
None of the observations are related to data integrity and management believes that they are addressable.
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