FDA 483 - Vantage Specialty Ingredients - May 02, 2022

Vantage Specialty Ingredients, Inc. in Linden, NJ, was inspected from April 26 to May 2, 2022, and cited for a significant issue regarding computer system validation. The firm failed to validate its Enterprise Resource Planning (ERP) and Laboratory Information Management System (LIMS) software, leading to unchecked accuracy of data for incoming and outgoing Active Pharmaceutical Ingredients and excipients. This indicates a lack of control over critical data management systems.