# FDA 483 - BioDuro, LLC - September 06, 2019

Source: https://www.keypedia.com/records/483/bioduro-llc/d422b794-23ae-4ee2-a7e2-14e1d74823ad

> FDA 483 for BioDuro, LLC on September 06, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: BioDuro, LLC
- Inspection Date: 2019-09-06
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Anchen Pharmaceuticals, Inc. in Irvine, CA, was cited for significant deficiencies in its manufacturing operations, particularly concerning laboratory controls and quality unit procedures. The inspection revealed issues with inadequate testing procedures for incoming materials and water hold times, as well as incomplete laboratory records for calculations. Furthermore, the firm failed to submit a required NDA Field Alert Report for a distributed product complaint and had an overdue investigation into foreign particles found during production.

## Related Documents

- [483 - 2024-02-23](https://www.keypedia.com/records/483/bioduro-llc/93797237-b041-42bf-b27c-afaf82fb39e9)

## Related Officers

- [SVP Consulting & Operations](https://www.keypedia.com/people/linda-f-murphy/a8b9737f-d5f4-4a36-8684-2fb050d008f2)

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