# Aurolife Pharma LLC – FDA 483, Aug 26, 2022

Source: https://www.keypedia.com/records/483/aurolife-pharma-llc/a5413264-1418-4ddc-ae62-3dadbcc49db5

> FDA 483 for Aurolife Pharma LLC on August 26, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Aurolife Pharma LLC
- Inspection Date: 2022-08-26
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Aurolife Pharma LLC in Durham, NC, from August 22-26, 2022, revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. The company's CAPA process failed to ensure the effectiveness of actions taken and did not adequately consider their potential adverse effects on finished products. This indicates a moderate severity issue related to quality system controls.

## Related Documents

- [483 - 2025-04-10](https://www.keypedia.com/records/483/aurolife-pharma-llc/dab66993-8516-44fc-bf38-26f7a17f3003) — date: April 10, 2025

## Related Officers

- [investigator](https://www.keypedia.com/people/tyler-r-courtney/08ea96c4-cd5a-4793-b7e4-fb2b9ee2b9ef)
- [Shelby N. Turner](https://www.keypedia.com/people/shelby-n-turner/77268f33-ae48-4e30-abad-4d79c1077185)

Company: https://www.keypedia.com/companies/aurolife-pharma-llc/24777a16-6dbb-467a-bed2-4d3065540a0d

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7