USFDA issues 2 observations for Alembic Pharma Karkhadi facility
New Delhi: Drugmaker, Alembic Pharma, today announced that the United States Food and Drug Administration (USFDA) has issued a Form 483 with 2 observations after the inspection at the company's Injectable Facility (F-3) located at Karkhadi.
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 inspection was conducted from 18th August 2022 to 30th August 2022.
"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 within the stipulated period," Alembic Pharma stated in its recent BSE filing.
"The Company is committed to maintain the highest quality standards and compliance at all times," Alembic further stated.
Read also: Alembic Pharma gets 10 USFDA observations for Karkhadi facility
Medical Dialogues team had earlier reported that Alembic Pharma had received Form 483 with 10 observations from the USFDA after the inspection at the company's Karkhadi Injectable Facility.
Read also: Alembic Pharma gets USFDA approval for Chlorthalidone Tablets
Alembic Pharmaceuticals Limited is an Indian multinational pharmaceutical company headquartered in Gujarat. The company is involved in manufacturing and marketing India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities. Its Manufacturing facilities, which cater to the International Generics markets are located at Panelav, Karkhadi, and Jarod in Gujarat. The company's APIs are manufactured at the Panelav and Karkhadi facilities.
