FDA EIR - Vantage Specialty Ingredients - February 08, 2016

Vantage Specialty Ingredients, a firm involved in relabeling bulk Active Pharmaceutical Ingredients (APIs) and repackaging various chemicals and pharmaceutical necessities, underwent a U.S. FDA cGMP surveillance inspection from February 8 to 10, 2016. The inspection, guided by Compliance Programs 7356.002F (API Process Inspection) and 7356.002B (Drug Repackers and Relabelers), as well as Q7 Good Manufacturing Practice Guidance for APIs, covered the company's materials, packaging and labeling, facilities and equipment, quality, and laboratory control systems. A significant finding was the firm's reported operational shift, confirming they no longer repackage API materials and have downsized related activities. Crucially, the inspection concluded without the issuance of an FDA Form 483, indicating no formal objectionable conditions were identified. However, investigators verbally communicated one specific deficiency: the company was not conducting annual GMP training for its personnel. In contrast, a previous inspection in August 2013 had resulted in two formal observations regarding deficiencies in the quality unit and the lack of appropriate validation for test results listed on API reports of analyses. For the current inspection, despite the verbal observation, the overall outcome was classified as "No Action Indicated" (NAI), suggesting general compliance. Nevertheless, the company was expected to address the identified lapse in annual GMP training to ensure ongoing adherence to regulatory expectations.