483
Vivalnk, Inc.FDA 483 - Vivalnk, Inc. - May 12, 2026
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Record Details
VivaInk, Inc. in Campbell, CA, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to submit Medical Device Reports (MDRs) within the required timeframe for serious injury events and exhibited inadequate documentation in risk management, complaint investigations, and corrective action procedures. These issues indicate a moderate level of non-compliance with medical device regulations.
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ID · ebe83a52-7c0c-40c0-9d82-f3dd00af45bd