Evolution Spine LLC

FDA 483 - Evolution Spine LLC

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Record Details

Evolution Spine, LLC, a medical device manufacturer in Dallas, TX, was inspected by the FDA, resulting in two observations. The inspection revealed deficiencies in translating device design into production specifications and in adequately controlling non-conforming products. These issues highlight concerns regarding the firm's quality system and adherence to regulatory requirements.

Company: Evolution Spine LLC
Product Type: Device
Office: Dallas District Office
Person: Gilbert Valdez (investigator)

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ID · b6917760-c713-44e3-a472-7796450c8c6e