USFDA inspection: Alembic Pharma gets 2 observations for Karkhadi facility

Written by Ruchika Sharma Published On 2023-03-25T11:15:59+05:30 | Updated On 25 March 2023 11:15 AM IST

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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.

"We would like to inform that the USFDA has conducted an inspection at Alembic Pharmaceuticals’ Injectable and Ophthalmic Facility (F-3) located at Karkhadi from 16th March, 2023 to 24th March, 2023," the company stated in a BSE filing.

"None of the observations are related to data integrity and management believes that they are addressable," the company further stated.

"The Company is preparing the response to the observations, which will be submitted to the USFDA within stipulated period. The Company is committed to maintain the highest quality standards and compliance at all times," Alembic added.

Medical Dialogues team had earlier reported that the Company had received an Establishment Inspection Report (EIR) from the USFDA for the inspection carried out at the company's Injectable Facility (F-3) at Karkhadi from 18th August, 2022 to 30th August, 2022.

Read also: Alembic Pharma Karkhadi facility gets EIR from USFDA

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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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751