# FDA 483 - Resolution Bioscience, Inc - April 08, 2022

Source: https://www.globalkeysolutions.net/records/483/resolution-bioscience-inc/b66f1aa8-3aed-42b2-8990-048649b08f05

> FDA 483 for Resolution Bioscience, Inc on April 08, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Resolution Bioscience, Inc
- Inspection Date: 2022-04-08
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Resolution Bioscience, Inc. in Kirkland, WA, a manufacturer, identified two observations. The firm failed to adequately implement its procedures for quality audits, specifically regarding internal audit documentation. Additionally, procedures for ensuring purchased products and services conform to requirements were not adequately implemented, with incomplete supplier management documentation noted.

## Related Officers

- [Terri E. Gibson](https://www.globalkeysolutions.net/people/terri-e-gibson/f1a80f95-a5c4-4cae-9a4b-e23f367770bb)
- [investigator](https://www.globalkeysolutions.net/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)

Company: https://www.globalkeysolutions.net/companies/resolution-bioscience-inc/30e46d7e-88c6-42f1-bd01-9b902a1952c6

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