# FDA 483 - Vivalnk, Inc. - December 10, 2021

Source: https://www.keypedia.com/records/483/vivalnk-inc/b855889e-d50e-4972-ab41-736ef147a596

> FDA 483 for Vivalnk, Inc. on December 10, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vivalnk, Inc.
- Inspection Date: 2021-12-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Vivalnk, Inc. in Campbell, CA, a manufacturer of medical devices, was cited with five observations during an FDA inspection from December 6-10, 2021. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for design changes, complaint handling, corrective and preventive actions, document control, and employee training. These issues indicate a systemic lack of adherence to established quality management practices for medical device manufacturing.

## Related Officers

- [Eileen M. Malecki](https://www.keypedia.com/people/eileen-m-malecki/775204bb-a174-4bf9-93dc-03c300f81af0)

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