# FDA 483 - Euclid Systems Corporation - August 15, 2025

Source: https://www.keypedia.com/records/483/euclid-systems-corporation/4003ef05-8313-4513-b2de-8b74feb167ee

> FDA 483 for Euclid Systems Corporation on August 15, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Euclid Systems Corporation
- Inspection Date: 2025-08-15
- Product Type: device
- Office Name: Baltimore District Office
- Summary: Euclid Vision Corporation in Sterling, VA, was inspected and received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in risk management procedures, finished device acceptance, and complaint handling, particularly concerning Class III lenses. These issues led to failures in identifying new hazards, ensuring product specifications, and adequately investigating and reporting complaints.

## Related Documents

- [483 - 2018-03-07](https://www.keypedia.com/records/483/euclid-systems-corporation/feba8449-58e7-447b-9f6f-d5c9e574c5f6)
- [EIR - 2019-02-21](https://www.keypedia.com/records/eir/euclid-systems-corporation/a0fa6eeb-fb81-4d7e-94c2-4a397b9b2102)

## Related Officers

- [Tiki Dixon](https://www.keypedia.com/people/tiki-dixon/b3160a2c-ef16-4fa2-b9b9-4c3a0ed17c5b)

Company: https://www.keypedia.com/companies/euclid-systems-corporation/9056f871-1da6-4163-8f5f-62f17fe343b5

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa
