# FDA 483 - Biogennix LLC - February 08, 2024

Source: https://www.globalkeysolutions.net/records/483/biogennix-llc/9f7c328c-e349-48c3-b695-7ba6594d6ceb

> FDA 483 for Biogennix LLC on February 08, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biogennix LLC
- Inspection Date: 2024-02-08
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Biogennix LLC in Irvine, CA, was inspected by the FDA, revealing significant deficiencies in their quality system. The firm failed to adequately maintain complaint files, establish effective corrective and preventive action procedures, and control nonconforming products. These issues indicate a lack of adherence to established quality management practices.

## Related Documents

- [EIR - 2012-04-18](https://www.globalkeysolutions.net/records/eir/biogennix-llc/d93e2064-a0fc-49bf-9ba3-a0b7f0776ed4)

## Related Officers

- [Scott D. Stevens](https://www.globalkeysolutions.net/people/scott-d-stevens/8d5a611a-4f0c-4e3a-9da7-3c872b08f91e)
- [Kevin N. Tran](https://www.globalkeysolutions.net/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.globalkeysolutions.net/companies/biogennix-llc/e1b0767d-32d6-4580-b9f4-f9ac3970d5e1

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6