483
Flexbar Machine CorpFlexbar Machine Corp – FDA 483, Apr 4, 2025
Record Details
An FDA inspection of Flexbar Machine Corp in Islandia, NY, a medical device manufacturer and importer, revealed a significant deficiency in their quality system. The firm failed to maintain written Medical Device Reporting (MDR) procedures and lacked the necessary electronic infrastructure for reporting serious injuries and deaths. This indicates a critical gap in their compliance with medical device reporting requirements.
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