Antibodies Inc – FDA 483, Mar 10, 2023

Antibodies Inc, a biological device and contract manufacturer in Davis, CA, received a Form FDA-483 with six observations. The inspection revealed significant deficiencies in quality system procedures, including inadequate control of storage areas, undocumented acceptance of incoming products, and failures in complaint management, CAPA, equipment maintenance, and internal audit independence. These issues indicate a systemic lack of robust quality oversight and documentation practices.