VITANG TECHNOLOGY LLC – FDA 483, Dec 8, 2023

VITANG TECHNOLOGY LLC in Tustin, CA, was inspected by the FDA, resulting in 11 observations, many of which are repeat findings from a previous inspection. The inspection revealed significant deficiencies across multiple quality system areas, including complaint handling, software validation, supplier management, CAPA procedures, equipment qualification, device history records, incoming product acceptance, UDI labeling, quality audits, management review, and personnel training. The firm appears to have a severely underdeveloped or non-compliant quality system, indicating a high level of non-compliance.