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

Source: https://www.keypedia.com/records/483/aurolife-pharma-llc/5b7e56fa-d5d5-4653-80c5-b9ecf43860b8

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

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## Details

- Record Type: 483
- Company Name: Aurolife Pharma LLC
- Inspection Date: 2025-04-10
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: **FDA 483 Summary: Aurolife Pharma LLC**

**Inspection Dates:** March 24, 2025 - April 10, 2025  
**Company:** Aurolife Pharma LLC  
**Location:** 2929 Weck Drive, Durham, NC 27709, USA  
**Type of Establishment:** Drug product manufacturer  

**Main Violations/Issues:**

1. **Quality System Deficiencies:** The quality control unit lacks written procedures and fails to adhere to existing protocols. Stability sample testing is inadequately controlled, leading to errors in sample selection and out-of-specification (OOS) results. Corrective actions were proposed but not verified for effectiveness.

2. **Stability Program Non-compliance:** Stability samples for finished products were not tested within the required timeframe, with some tests delayed by six months or more. Documentation inaccuracies regarding testing dates were noted.

3. **Access Control Issues:** Quality control analysts have unauthorized access to R&D projects within the chromatography data system.

4. **Change Control Misclassification:** Changes impacting product quality and validation status were improperly classified as minor, bypassing necessary scrutiny.

5. **Lack of New Product Introduction Procedures:** No established procedures for introducing new drug products, risking impacts on validated processes and equipment.

6. **Inadequate Data Review:** Comprehensive reviews of raw manufacturing and analytical data, including audit trails, are not conducted by Quality Assurance prior to final batch record approval.

7. **Environmental Monitoring Gaps:** Temperature, humidity, and pressure differentials in manufacturing areas are not continuously monitored, risking unaddressed excursions.

8. **Deficient Discrepancy Reviews:** Investigations into device malfunctions and OOS results were found lacking, with inadequate corrective actions to prevent recurrence.

**Regulatory Framework:** The inspection was conducted under the authority of the FDA"s Center for Drug Evaluation and Research (CDER).

**Required Actions:** Aurolife Pharma LLC must address these violations by implementing effective corrective and preventive actions,

## 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/dab66993-8516-44fc-bf38-26f7a17f3003)

## Related Officers

- [Laurimer X. Kauian-Torres](https://www.keypedia.com/people/laurimer-x-kauian-torres/0be42c7a-e6c6-435e-bf56-74ca7fe413ec)
- [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/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c