# FDA 483 - Ward Photonics, LLC - January 19, 2023

Source: https://www.keypedia.com/records/483/ward-photonics-llc/ce1be824-3b00-452b-a261-b0849a009f70

> FDA 483 for Ward Photonics, LLC on January 19, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Ward Photonics, LLC
- Inspection Date: 2023-01-19
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Ward Photonics, LLC, a medical device manufacturer in Cocoa Beach, FL, was inspected regarding its LED light therapy systems. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for complaint handling, corrective and preventive actions, and medical device reporting. Several observations were repeats, indicating persistent issues with the firm's quality management system.

## Related Officers

- [investigator](https://www.keypedia.com/people/stanley-b-eugene/4708f43e-0592-4c24-b276-d9f9092788a3)

Company: https://www.keypedia.com/companies/ward-photonics-llc/51e66658-3d19-438f-9dfa-25240f73af2c

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6