483
MedMira Laboratories Inc.FDA 483 - MedMira Laboratories Inc. - November 18, 2021
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Record Details
An FDA inspection of MedMira Laboratories Inc. in Halifax revealed significant issues with medical device reporting and complaint handling. The firm failed to submit timely MDR reports for false positive HIV test results and lacked adequate procedures for evaluating complaints to determine MDR reportability. These deficiencies indicate a serious breakdown in their quality system regarding post-market surveillance.
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ID · 022a4b56-6cae-4222-94b7-de387bfc3c92