483
Reflow MedicalFDA 483 - Reflow Medical - March 05, 2026
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Record Details
Reflow Medical, a medical device manufacturer in Lake Forest, CA, received two observations during an FDA inspection. The firm was cited for not having documented procedures for verifying the effectiveness of preventive actions. Additionally, their criteria for evaluating and selecting suppliers were found to be inadequate, failing to properly assess risk and ensure appropriate quality agreements.
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