FDA 483 - Vantage Specialty Ingredients Inc - June 27, 2023

Vantage Specialty Ingredients, Inc. in Englewood, OH, an API manufacturer, was cited for significant deficiencies during an FDA inspection, including incomplete master production records for Benzoyl Peroxide and a failure to document and timely investigate deviations. The firm also lacked an adequate stability testing program for Salicylic Acid and Benzoyl Peroxide, and had insufficient controls for computerized laboratory systems to prevent unauthorized data manipulation.