FDA 483 - RAY VISION INC. - December 17, 2021

RAY VISION INC., a manufacturer and importer of ophthalmic devices in Lake Forest, CA, was inspected by the FDA and received 11 observations. The inspection revealed a severe lack of established procedures across nearly all aspects of their quality system, including complaint handling, purchasing, product acceptance, non-conforming product control, product identification, device history records, document control, MDR, CAPA, and overall quality system management. Additionally, the firm failed to maintain adequate distribution records.