# FDA 483 - RIGHTEYE, LLC - July 08, 2022

Source: https://www.keypedia.com/records/483/righteye-llc/4d7d2302-03aa-451d-a490-db6a6e21f543

> FDA 483 for RIGHTEYE, LLC on July 08, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RIGHTEYE, LLC
- Inspection Date: 2022-07-08
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: RIGHTEYE, LLC, a medical device manufacturer in Bethesda, MD, was inspected by the FDA, resulting in 10 observations. The inspection revealed significant deficiencies across its quality management system, including failures in design control, management review, quality audits, complaint handling, nonconforming product control, acceptance activities, supplier management, software validation, and employee training. These issues indicate a broad lack of established and followed procedures essential for ensuring device quality and regulatory compliance.

## Related Documents

- [WARNING_LETTER - 2022-07-08](https://www.keypedia.com/records/warning_letter/righteye-llc/9e27ad86-4b31-4ebd-9034-3defc8ad22bf)

## Related Officers

- [Jude C. Dike](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)
- [Nadia R. Barreda](https://www.keypedia.com/people/nadia-r-barreda/ef624359-957a-45e4-89c9-5b5ff215c6aa)

Company: https://www.keypedia.com/companies/righteye-llc/bca3f1bc-4f9c-44b8-8436-ac9a14dbb5f2

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64