FDA 483 - Aurolife Pharma LLC - April 10, 2025

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.