FDA 483 - Aurorium LLC - July 31, 2025

Aurorum LLC, an API manufacturer in Zeeland, MI, was cited for significant deficiencies in its quality unit operations and product labeling during an FDA inspection. The inspection revealed inadequate investigations into critical deviations, out-of-specification (OOS) results, and customer complaints, alongside a failure to conduct stability studies for API products. Additionally, finished API product labels lacked required expiry or retest dates.