By: IPP Bureau
Last updated : December 20, 2022 10:24 am
None of the observations are related to data integrity and management believes that they are addressable
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.
The company is preparing the response to the observations, which will be submitted to the USFDA within the stipulated period. Alembic Pharmaceuticals is committed to maintain the highest quality standards and compliance at all times.