# FDA 483 - BioDuro, LLC - February 23, 2024

Source: https://www.keypedia.com/records/483/bioduro-llc/93797237-b041-42bf-b27c-afaf82fb39e9

> FDA 483 for BioDuro, LLC on February 23, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: BioDuro, LLC
- Inspection Date: 2024-02-23
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: BioDuro, LLC, a drug manufacturer in Irvine, CA, was inspected by the FDA and received a Form 483 with eight observations. The inspection revealed significant issues across quality control, production processes, and laboratory controls, including persistent dissolution failures, inadequate equipment design, unvalidated process parameters, and insufficient annual product reviews. These findings indicate a need for substantial improvements in the firm's quality management system to ensure drug product quality and compliance.

## Related Documents

- [483 - 2019-09-06](https://www.keypedia.com/records/483/bioduro-llc/d422b794-23ae-4ee2-a7e2-14e1d74823ad)

## Related Officers

- [Wenzheng Zhang](https://www.keypedia.com/people/wenzheng-zhang/44b1afce-5ba2-4013-82ac-52c6374c0be4)
- [Bryan A Chavez](https://www.keypedia.com/people/bryan-a-chavez/72f37fa8-535b-4540-813c-9dade47a22d9)
- [Laurence L Adeshoun](https://www.keypedia.com/people/laurence-l-adeshoun/e7e3a830-f382-48b1-af93-ad0020cd45cc)

Company: https://www.keypedia.com/companies/bioduro-llc/ea6debd9-54f2-4570-a8b6-f62b6f60c207

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