483
iVu Imaging CorpFDA 483 - iVu Imaging Corp - March 05, 2025
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Record Details
An FDA inspection of iVU Imaging Corp, a medical device manufacturer in Southlake, TX, identified one observation related to their quality system. The firm's device history records did not demonstrate that devices were manufactured in accordance with regulations, specifically regarding the maintenance of complete labeling records. This indicates a moderate severity finding concerning documentation and quality control practices.
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ID · 4339c4f2-ff3a-4fd2-82a5-ba3aa4870246