# FDA 483 - Aurolife Pharma LLC - April 10, 2025

Source: https://www.keypedia.com/records/483/aurolife-pharma-llc/dab66993-8516-44fc-bf38-26f7a17f3003

> FDA 483 for Aurolife Pharma LLC on April 10, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Aurolife Pharma LLC
- Inspection Date: 2025-04-10
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Aurolife Pharma LLC, a drug product manufacturer in Durham, NC, was cited for significant deficiencies across its quality system, laboratory controls, facilities, and equipment. The inspection revealed issues with stability testing, OOS investigations, change control, environmental monitoring, equipment cleaning, pest control, calibration, and the effectiveness of corrective and preventive actions, indicating a broad lack of adherence to GMP regulations. The firm also failed to submit a Field Alert Report in a timely manner for a distributed product with device malfunctions.

## Related Documents

- [483 - 2022-08-26](https://www.keypedia.com/records/483/aurolife-pharma-llc/a5413264-1418-4ddc-ae62-3dadbcc49db5)
- [483 - 2025-04-10](https://www.keypedia.com/records/483/aurolife-pharma-llc/5b7e56fa-d5d5-4653-80c5-b9ecf43860b8)

## Related Officers

- [Laurimer Kuilan-Torres](https://www.keypedia.com/people/laurimer-kuilan-torres/a7f49e33-9d35-4dfe-8bcc-d369d3834ef4)
- [Yiwei Li](https://www.keypedia.com/people/yiwei-li/e5ea2c24-8e1e-43be-be23-e276b8848cff)

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