# FDA 483 - Amneal Pharmaceuticals Private Ltd. - December 23, 2022

Source: https://www.globalkeysolutions.net/records/483/amneal-pharmaceuticals-private-ltd/b6047e86-e443-40b8-8261-c624ee2c233e

> FDA 483 for Amneal Pharmaceuticals Private Ltd. on December 23, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Amneal Pharmaceuticals Private Ltd.
- Inspection Date: 2022-12-23
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Amneal Pharmaceuticals Private Limited in Ahmedabad, Gujarat, a parenteral drug manufacturer, revealed significant deficiencies across its aseptic processing operations. The firm failed to adequately verify aseptic practices, maintain proper environmental monitoring, and ensure appropriate airflow visualization, indicating a lack of control over critical manufacturing processes. These issues collectively raise concerns about the sterility assurance and overall quality of the drug products produced.

## Related Documents

- [483 - 2018-04-24](https://www.globalkeysolutions.net/records/483/amneal-pharmaceuticals-private-ltd/244d0cc8-eaef-4da5-956f-0bd2773d8823)
- [483 - 2018-04-24](https://www.globalkeysolutions.net/records/483/amneal-pharmaceuticals-private-ltd/ca761aa3-3f67-47d0-8e0a-ec569a845796)
- [483 - 2022-12-23](https://www.globalkeysolutions.net/records/483/amneal-pharmaceuticals-private-ltd/4e198411-7bc6-4beb-bf08-921ec3ec35e8)
- [483 - 2024-06-19](https://www.globalkeysolutions.net/records/483/amneal-pharmaceuticals-private-ltd/f120f87b-ed0a-4330-8dcd-f96c87af7321)

## Related Officers

- [Thomas J. Arista](https://www.globalkeysolutions.net/people/thomas-j-arista/37905892-3285-4f3f-b4b5-f963df1e59d3)

Company: https://www.globalkeysolutions.net/companies/amneal-pharmaceuticals-private-ltd/95002f12-1dab-4e55-82a6-bed955c79358

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1