US Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceutical’s General Oral Solid Formulation Facility located at Panelav from March 9, 2020 to March 13, 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.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.