Vasomedical Inc – FDA 483, Apr 6, 2026
An FDA inspection of Vasomedical Inc. in Plainview, NY, revealed one significant observation related to inadequate controls over outsourced processes for medical device manufacturing. The firm failed to establish formal quality agreements with suppliers for devices like ECG, Ambulatory Blood Pressure Monitors, and Lumenair, and lacked documentation for maintaining design and risk analysis files. This indicates a serious lapse in ensuring product conformity and quality system responsibilities for outsourced activities.
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