483
Resolution Biomedical IncResolution Biomedical Inc – FDA 483, Dec 12, 2019
Record Details
An FDA inspection of Resolution Biomedical Inc, a medical device repackager in Tustin, CA, revealed significant deficiencies in their quality system. The firm failed to adequately establish and follow procedures for finished device acceptance, corrective and preventive actions, and purchasing controls. These issues indicate a systemic breakdown in maintaining quality standards for their repackaged medical devices.
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ID · 44eecd5d-b40c-41a8-a0d5-f5645203cb98
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