Cytovance Biologics Inc. – FDA 483, Jun 8, 2026

An FDA inspection of Cytovance Biologics Inc. in Oklahoma City, OK, an API manufacturer, revealed significant deficiencies across multiple systems. The firm was cited for repeat observations concerning facility maintenance and equipment qualification, alongside failures in cleaning validation, deviation investigations, raw material testing justification, and labeling procedures. These issues indicate a lack of adequate control over critical manufacturing processes and quality systems.