# FDA 483 - Vivalnk, Inc. - May 12, 2026

Source: https://www.keypedia.com/records/483/vivalnk-inc/ebe83a52-7c0c-40c0-9d82-f3dd00af45bd

> FDA 483 for Vivalnk, Inc. on May 12, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vivalnk, Inc.
- Inspection Date: 2026-05-12
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

## Related Documents

- [483 - 2021-12-10](https://www.keypedia.com/records/483/vivalnk-inc/b855889e-d50e-4972-ab41-736ef147a596)

## Related Officers

- [Kenya Destin](https://www.keypedia.com/people/kenya-destin/1a367d64-8171-4dfd-bb1f-78d8b96a99f5)

Company: https://www.keypedia.com/companies/vivalnk-inc/05ec5bb4-edcb-4858-ae99-483edb4ec415

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b