# FDA 483 - Lupin Limited (Biotech Division) - October 14, 2022

Source: https://www.globalkeysolutions.net/records/483/lupin-limited-biotech-division/1b18d11a-1dd5-459b-bcba-13c20a20aa52

> FDA 483 for Lupin Limited (Biotech Division) on October 14, 2022. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lupin Limited (Biotech Division)
- Inspection Date: 2022-10-14
- Office Name: Division of Biotechnology Manufacturing
- Summary: This FDA Form 483 details numerous deficiencies observed during an inspection of a drug product manufacturing facility.

**Facility and Operations:** The inspection focused on aseptic monitoring for a fill line (EQP/DPD/001) used for drug product manufacture, including RABS (Restricted Access Barrier System) and surrounding Grade A/B areas. It also covered raw material handling, utility systems (e.g., water for injection), and quality control laboratories.

**Violations and Observations:**
*   **Aseptic Monitoring Inadequacies:** Settling plate placement and exchange procedures in RABS were inadequate, leading to excessive interventions. Personnel environmental monitoring was not representative.
*   **Product Evaluation Deficiencies:** Failure to adequately evaluate and take remedial action for actionable microbial contamination in a Grade A area (e.g., 4 CFU Acrococei Viridans, a human pathogen, with no further testing).
*   **Environmental Monitoring Deficiencies:**
    *   Grade A surrounding areas not monitored to Grade A standards (e.g., nonviable particle and active air monitoring not dynamic, limited settle plate placement).
    *   Active air sampling not conducted dynamically in RABS during filling.
    *   Personnel performing RABS interventions not consistently monitored.
    *   Sterilized components unwrapped outside RABS in Grade A surrounding area.
    *   Lack of environmental monitoring in frequently touched/high-traffic areas (e.g

## Related Documents

- [483 - 2022-10-14](https://www.globalkeysolutions.net/records/483/lupin-limited-biotech-division/fba695c4-7c84-4c77-be5a-4e943aef6afb)
- [CRL - Unknown Date](https://www.globalkeysolutions.net/records/crl/lupin-limited-biotech-division/109857c7-16e4-42ca-9b61-1e767b235dbb)
- [483 - 2025-09-19](https://www.globalkeysolutions.net/records/483/lupin-limited-biotech-division/25ae6777-20e4-4f88-9cb0-cd2ad37ec3be)

## Related Officers

- [Liang Liu (U.S. Agent)](https://www.globalkeysolutions.net/people/liang-liu-us-agent/36c5089e-8cc2-4971-b592-cb6196b5d303)
- [recipient](https://www.globalkeysolutions.net/people/yan-wang/9152655d-5458-4869-8e15-3227cec56699)
- [Cynthia Jim](https://www.globalkeysolutions.net/people/cynthia-jim/e0f1c8a7-d787-442a-911c-61e37cd806a6)
- [Senior Regulatory Specialist](https://www.globalkeysolutions.net/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.globalkeysolutions.net/companies/lupin-limited-biotech-division/71a104da-9365-4836-afc4-9c80c8a9c4f0

Office: https://www.globalkeysolutions.net/offices/division-of-biotechnology-manufacturing/3e3018f1-aa48-4010-a554-96f557f17c55