483
Vasomedical IncFDA 483 - Vasomedical Inc - January 09, 2023
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Record Details
An FDA inspection of Vasomedical Inc in Plainview, NY, from January 4-9, 2023, revealed a significant quality system deficiency. The firm failed to formally appoint a management representative responsible for ensuring quality system requirements are met and reporting on its performance. This indicates a lack of documented oversight in a critical area of quality management.
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ID · e2ed3fa8-8d43-4800-a1c4-f2589d10a309