FDA 483 - Aurorium LLC - April 09, 2019

The FDA inspected Vertellus LLC in Zeeland, MI, and issued a Form 483 with seven observations. The inspection revealed significant deficiencies in quality unit oversight, documentation practices, material control, water suitability, and laboratory controls, indicating a lack of adherence to established procedures for API manufacturing. These issues include failure to investigate critical deviations, inadequate equipment log reviews, insufficient incoming material identity testing, and poor control over manual data integrations.