# FDA 483 - Protech Leaded Eyewear - March 10, 2025

Source: https://www.keypedia.com/records/483/protech-leaded-eyewear/fa0dac6e-9843-4334-b895-17ba84eef908

> FDA 483 for Protech Leaded Eyewear on March 10, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Protech Leaded Eyewear
- Inspection Date: 2025-03-10
- Product Type: device
- Office Name: Florida District Office
- Summary: Protech Leaded Eyewear in Lake Park, FL, was inspected from March 4-10, 2025, and received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding the establishment of design control procedures, quality audit procedures, and the adequate maintenance of complaint files, with the latter being a repeat observation.

## Related Documents

- [483 - 2018-12-14](https://www.keypedia.com/records/483/protech-leaded-eyewear/a5233031-9d93-486f-8156-07a6bab0250e)

## Related Officers

- [David M. Wilkinson](https://www.keypedia.com/people/david-m-wilkinson/5e81ba03-7602-46d6-b675-26efc77d28db)

Company: https://www.keypedia.com/companies/protech-leaded-eyewear/760ca8ff-6ca0-4f16-8e4b-83f022a9293a

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9