483
Cardiocommand Inc.Cardiocommand Inc. – FDA 483, Jul 30, 2026
Record Details
An FDA inspection of CardioCommand, Inc. in Tampa, FL, a medical device manufacturer, revealed a significant lack of documented risk management processes for their (b)(4) PMA (b)(4) product. The firm acknowledged the absence of a formal risk management system, leading to a deficiency in required records for identifying and mitigating device hazards. This indicates a serious compliance issue regarding product safety and quality system regulations.
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ID · 8e837458-b76d-443e-843b-c276cf097457
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