OPTIMOTION IMPLANTS LLCOctober 20, 2023

FDA 483 - OPTIMOTION IMPLANTS LLC - October 20, 2023

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Record Details

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.

Company: OPTIMOTION IMPLANTS LLC
Inspection Date: October 20, 2023
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Brandon P. Thompson

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ID · 22c6a7b5-243c-4c7b-9587-af248531184c