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