FDA 483 - Aurolife Pharma LLC - April 10, 2025

**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,