# FDA 483 - Protech Leaded Eyewear - December 14, 2018

Source: https://www.keypedia.com/records/483/protech-leaded-eyewear/a5233031-9d93-486f-8156-07a6bab0250e

> FDA 483 for Protech Leaded Eyewear on December 14, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Protech Leaded Eyewear
- Inspection Date: 2018-12-14
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Protech Leaded Eyewear in Lake Park, FL, revealed significant deficiencies across its quality system. The firm failed to establish adequate procedures for Medical Device Reporting, complaint handling, corrective and preventive actions, statistical techniques, supplier evaluation, and document control. These issues indicate a broad lack of compliance with FDA regulations for medical device manufacturing.

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## 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/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6