FDA 483 - AURORIUM LLC - March 02, 2026

Aurorium LLC, an API manufacturer in Midlothian, TX, received a Form FDA 483 with five observations during an inspection from March 2-6, 2026. The observations highlight significant deficiencies in facility and equipment maintenance, failure to investigate out-of-specification test results for endotoxins, and widespread failures in Quality Unit oversight. Additionally, the firm failed to conduct its annual product quality review and lacked proper testing for a critical production component.