483
Brain Scientific IncFDA 483 - Brain Scientific Inc - July 03, 2019
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Record Details
Memory MD, Inc., a medical device manufacturer in New York, NY, was inspected by the FDA from June 27 to July 3, 2019. The inspection revealed significant deficiencies in design control documentation, including inadequate validation results and missing design review records. Additionally, the firm failed to adequately maintain device history records, specifically regarding incoming inspection forms.
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ID · 940c9482-4013-4022-be38-7aad24967675