Alembic Pharma gets one procedural observation for Vadodara facility
Vadodara: Alembic Pharma has announced that the United States Food and Drug Administration (USFDA) has concluded an inspection with one procedural observation at the Company's Bioequivalence Facility located at Vadodara.
The inspection was conducted from 3rd March, 2025 to 7th March, 2025.
This was a scheduled inspection. The USFDA issued a Form 483 with one procedural observation.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
"The Company will provide comprehensive response to USFDA for the observations within the stipulated period. The Company is committed to maintain the highest quality standards and compliance at all times," Alembic stated in a filing.
Read also: Alembic Pharma bags USFDA final approval for schizophrenia drug Brexpiprazole
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
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