Statrad, LLCOctober 30, 2019

FDA 483 - Statrad, LLC - October 30, 2019

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Record Details

NucleusHealth, LLC in San Diego, CA, a specification developer and manufacturer, was inspected by the FDA. The inspection revealed significant issues with design controls for their Nucleus.io software, including inadequate design input procedures and lack of verification testing documentation. Additionally, the firm failed to maintain a device master record and had not adequately established training procedures for personnel.

Company: Statrad, LLC
Inspection Date: October 30, 2019
Product Type: Device
Office: Division of Pharmaceutical Quality Operations IV
Person: Jenny L Mccardell

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ID · 3af5f5e0-d6d3-411f-b219-851d24abf589