By: IPP Bureau
Last updated : October 19, 2022 8:32 am
None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable
The United States Food and Drug Administration (USFDA) conducted an inspection at Alembic Pharmaceuticals Limited Oncology Injectable Formulation Facility located at Panelav from 4-14 October, 2022.
The USFDA issued Form 483 with four procedural observations. The company is preparing the response to the observations, which will be submitted to the USFDA within the stipulated period.
The company is also committed to maintain the highest quality standards and compliance at all times.