# FDA 483 - EirGenix, Inc., Zhubei Branch - June 16, 2022

Source: https://www.globalkeysolutions.net/records/483/eirgenix-inc-zhubei-branch/d99a3303-3bb7-4480-b432-32589186d4f3

> FDA 483 for EirGenix, Inc., Zhubei Branch on June 16, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: EirGenix, Inc., Zhubei Branch
- Inspection Date: 2022-06-16
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: This FDA Form 483 report for EirGenix, Inc., Zhubei Branch, identifies significant deficiencies across its quality systems. The firm failed to adequately initiate, investigate, and document deviations and out-of-specification results, and lacked proper procedures for preventing cross-contamination in its multi-product facility. Additional issues include ineffective employee training, failures in Quality Unit responsibilities, inadequate analytical methods and equipment qualification, and insufficient monitoring of processes, facilities, and laboratory instruments, indicating a broad lack of control over critical operations.

## Related Officers

- [Lead  Biologist](https://www.globalkeysolutions.net/people/leiyun-w-boone/454ce531-ae82-4ae4-9b3d-8e4e8afed127)
- [Yun Wu](https://www.globalkeysolutions.net/people/yun-wu/ae378596-ea82-4254-b169-b592878202eb)

Company: https://www.globalkeysolutions.net/companies/eirgenix-inc-zhubei-branch/34ccb508-83f1-4254-b860-ad0554ed9064

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd