FDA 483 - APC Pharma Carlsbad

APC Pharma Carlsbad, a biologics manufacturer in Carlsbad, CA, was cited for six observations during an FDA inspection. The inspection revealed significant issues primarily related to aseptic processing, contamination control, equipment management, and procedural deficiencies, indicating a lack of adequate controls to ensure product quality and sterility. These conditions suggest a moderate level of severity regarding compliance with manufacturing standards.