# FDA 483 - OPTIMOTION IMPLANTS LLC - October 20, 2023

Source: https://www.keypedia.com/records/483/optimotion-implants-llc/22c6a7b5-243c-4c7b-9587-af248531184c

> FDA 483 for OPTIMOTION IMPLANTS LLC on October 20, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OPTIMOTION IMPLANTS LLC
- Inspection Date: 2023-10-20
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: OPTIMOTION IMPLANTS LLC in Orlando, FL, a specification developer, was inspected by the FDA from October 16-20, 2023. The inspection revealed a significant quality system deficiency where the firm's Material Review Board failed to implement its nonconforming product procedure, specifically regarding the documentation of adverse effects from rework activities. This indicates a breakdown in ensuring product quality and safety after rework.

## Related Officers

- [Brandon P. Thompson](https://www.keypedia.com/people/brandon-p-thompson/a4e7da4f-2e9c-497c-ae4c-9168a9678b91)

Company: https://www.keypedia.com/companies/optimotion-implants-llc/1e808829-8d4d-498c-b09b-94ad9e609f68

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