FDA 483 - Biovectra, Inc. - April 19, 2024

BioVectra, Inc. in Charlottetown, Canada, an API contract manufacturer, was cited for two significant deficiencies during an FDA inspection. The firm failed to follow written procedures for annual product reviews of Active Pharmaceutical Ingredients, a repeated deficiency, and lacked adequate laboratory controls to ensure API identity and quality, specifically regarding infrared spectroscopy testing. These issues indicate a breakdown in quality control and adherence to established standards.