The United States Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals Formulation Facility located at Panelav in Gujarat from March 12, 2018 to March 20, 2018. This was a scheduled inspection and at the end of the inspection, the USFDA issued a Form 483 with 3 observations.
None of the observations are related to data integrity or repetitive in nature. The company is preparing the response to the observations, which will be submitted to the USFDA shortly.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907. The company manufactures and markets generic pharmaceuticals products all over the world.
