# FDA 483 - LifeNet Health Northwest, LLC - April 11, 2019

Source: https://www.globalkeysolutions.net/records/483/lifenet-health-northwest-llc/46a27a79-6c2c-4963-be71-4573659f38e7

> FDA 483 for LifeNet Health Northwest, LLC on April 11, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LifeNet Health Northwest, LLC
- Inspection Date: 2019-04-11
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: LifeNet Health Northwest, LLC, a human tissue processor in Renton, WA, was cited for significant deficiencies during an FDA inspection. Observations included the distribution of contaminated human cells, tissues, and cellular and tissue-based products (HCT/Ps), inadequate controls to prevent cross-contamination, and poor facility maintenance. Additionally, the firm failed to properly validate computer software prior to its implementation.

## Related Officers

- [Manager, Data Science and Engineering](https://www.globalkeysolutions.net/people/kelly-d-moore/a5778f12-e968-4fc9-8391-b2cb5753232a)
- [Investigator](https://www.globalkeysolutions.net/people/peter-s-kessler/f3a9dea7-3a2d-4c86-9ec6-97791f9b6c21)

Company: https://www.globalkeysolutions.net/companies/lifenet-health-northwest-llc/6dcec57e-402b-4d37-8f48-6734d7259003

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822