# FDA 483 - Sota Precison Optics Inc - August 15, 2025

Source: https://www.keypedia.com/records/483/sota-precison-optics-inc/0bf4d681-5eac-41e5-93ed-b41651b3ba8b

> FDA 483 for Sota Precison Optics Inc on August 15, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sota Precison Optics Inc
- Inspection Date: 2025-08-15
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Sota Precison Optics Inc., a manufacturer of dental x-ray systems in Orange, CA, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, complaint handling, and finished device acceptance. These issues indicate a lack of robust controls over critical quality processes.

## Related Officers

- [Jae H. Lee](https://www.keypedia.com/people/jae-h-lee/ce701294-2a54-48f2-8a34-e93231bc2d88)
- [Kevin N. Tran](https://www.keypedia.com/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.keypedia.com/companies/sota-precison-optics-inc/36df31c9-2523-4199-83b2-c9e45ec24969

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b