USFDA inspection: Alembic Pharma gets 2 observations for Karkhadi facility

Vadodara: Drugmaker, Alembic Pharmaceuticals, has announced that the US Food and Drug Administration (USFDA) has issued a Form 483 with two minor procedural observations following an inspection at the company's Injectable and Ophthalmic Facility (F-3) located at Karkhadi, Gujarat.

 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 16th March, 2023 to 24th March, 2023.

Headquartered in Vadodara, Gujarat, Alembic Pharmaceuticals Limited is involved in manufacturing and marketing India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities. The company was founded in 1907. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic has a cumulative total of 183 ANDA approvals (160 final approvals and 23 tentative approvals) from USFDA.

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