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

Source: https://www.globalkeysolutions.net/records/483/amneal-pharmaceuticals-private-ltd/4e198411-7bc6-4beb-bf08-921ec3ec35e8

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

---

## Details

- Record Type: 483
- Company Name: Amneal Pharmaceuticals Private Ltd.
- Inspection Date: 2022-12-23
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: This FDA Form 483 document details observations from an inspection of a facility manufacturing sterile drug products, specifically focusing on aseptic processing areas.

**Facility and Operations:** The facility operates aseptic fill lines within Restricted Access Barrier Systems (RABS) and utilizes HEPA filters for Grade A areas. Production involves manual activities within these controlled environments.

**Violations and Observations:**
*   **Aseptic Process Monitoring:** In Process Quality Assurance (IPQA) visual verification of aseptic practices lacks documented rationale for adequacy, and "dos and don'ts" checklists do not delineate Grade A areas. QA does not routinely observe aseptic filling operations on most manufacturing days.
*   **Personnel Practices:** Production operators access RABS through a small panel, requiring awkward body movements that may compromise aseptic conditions. Goggles worn by operators during aseptic processing were not appropriately fitted, leaving open spaces.
*   **Disinfectant Qualification:** Disinfectant qualification studies (AP-QCM-MIS-43-00, AP-QCM-MIS-039-00) did not include all cleanroom surfaces/materials (e.g., parts wheels, sealing materials, gowning material). The specific type of disinfectant used in one study was not known.
*   **Cleaning and Sanitization:** Diffusers assisting HEPA filter air in RABS are not cleaned and sanitized.
*   **Environmental Monitoring (EM) Program:**
    *   The EM sampling program

## 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/b6047e86-e443-40b8-8261-c624ee2c233e)
- [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/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6