FDA EIR - Vantage Specialty Ingredients Inc - February 16, 2018

An FDA inspection of Vantage Specialty Ingredients Inc., located in Englewood, OH, was conducted from February 12-16, 2018. This was an abbreviated surveillance inspection focused on the company's Active Pharmaceutical Ingredient (API) manufacturing processes, following CPGM 7356.002F. The inspection revealed four significant observations documented on an FDA Form 483. Firstly, the quality control unit was found deficient, specifically regarding delayed initiation of investigations into customer complaints, such as a "heavy graininess" issue with their Benzoyl Peroxide Gel API, and a failure to fully execute corrective and preventative actions. Secondly, there was inadequate oversight of laboratory electronic systems and data, as a QC Chemist possessed full administrative rights within critical software, allowing for data manipulation. Thirdly, the firm lacked comprehensive calibration and maintenance programs for key analytical equipment, including HPLC and FT-NIR systems, which are essential for material identification, assay, and impurity profiling. Additionally, a written procedure for inactive ingredient identification testing using FT-NIR was missing. Finally, batch records for the Benzoyl Peroxide API were deficient, as critical manufacturing steps, such as the addition of raw materials and final product weight, lacked independent second verification. Vantage Specialty Ingredients Inc. management acknowledged these observations and committed to providing a written response within 15 business days, detailing their corrective actions.