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

Source: https://www.keypedia.com/records/483/ray-vision-inc/be835b63-1ef8-4efd-a612-f249ef60be70

> FDA 483 for RAY VISION INC. on December 17, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RAY VISION INC.
- Inspection Date: 2021-12-17
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Officers

- [Investigator](https://www.keypedia.com/people/alexandria-l-capuano/f76c710a-613f-42b2-8958-1292fa329112)

Company: https://www.keypedia.com/companies/ray-vision-inc/bcf5ec54-6895-4f92-a321-6d32de3130d6

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6