Alembic Pharma gets 10 USFDA observations for Karkhadi facility
Vadodara: Drugmaker, Alembic Pharmaceuticals, has recently announced that the United States Food and Drug Administration (USFDA) has issued Form 483 with 10 observations after the inspection at the company's Injectable Facility (F-3) located at Karkhadi, Gujarat. The inspection was conducted from 28th October, 2021 to 10th November, 2021.
"We would like to inform that the United States Food and Drug Administration (US FDA) has conducted an inspection at Alembic Pharmaceuticals' Injectable Facility (F-3) located at Karkhadi from 28th October, 2021 to 10th November, 2021," the company said in a BSE filing.
The USFDA issued a Form 483 with 10 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," the company added.
"The Company is committed to maintain the highest quality standards and compliance at all times," Alembic further added.
Earlier, the company had received Establishment Inspection Report (EIR) from US Food and Drug Administration (USFDA) for the inspection carried out at its Karkhadi facility.
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat.
The company is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.
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