FDA 483 - VVF Illinois Services LLC - September 26, 2025

VVF Illinois Services LLC, a contract manufacturer in Montgomery, IL, was inspected and cited for multiple deficiencies in its quality system. Key issues include inadequate testing of active ingredients, lack of defined timeframes for OOS investigations, deficient equipment cleaning validation, and poor facility sanitation with pest activity. The firm also failed to properly document batch yields, maintain reserve samples, and manage the transition to a computerized system through its change control process.