483
Meddev CorpFDA 483 - Meddev Corp - March 12, 2025
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Record Details
An FDA inspection of Meddev Corp in Sunnyvale, CA, revealed two significant observations. The firm failed to report a correction or removal of mislabeled medical devices that were surgically implanted, despite acknowledging a risk to health. Additionally, Meddev Corp did not adequately establish records for acceptable suppliers and contractors, lacking critical audit documentation.
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