# FDA 483 - W. L. Gore & Associates, Inc. - July 26, 2018

Source: https://www.globalkeysolutions.net/records/483/w-l-gore-associates-inc/6f267732-87d3-4955-bef2-71619e7b4b9f

> FDA 483 for W. L. Gore & Associates, Inc. on July 26, 2018. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: W. L. Gore & Associates, Inc.
- Inspection Date: 2018-07-26
- Product Type: other
- Office Name: Denver District Office
- Summary: W. L. Gore & Associates, Inc. in Flagstaff, AZ, a nonclinical laboratory, received a Form 483 for deficiencies in its quality assurance unit. The inspection revealed that the quality assurance unit failed to adequately monitor studies to ensure conformance with FDA GLP regulations. Specifically, equipment used in studies was misidentified, indicating a breakdown in quality control and data integrity for nonclinical studies.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/vickie-j-kanion/4ec38844-d90f-490e-bdfb-7bcee20fcc90)

Company: https://www.globalkeysolutions.net/companies/w-l-gore-associates-inc/45cb5ecc-c2e5-40e9-acca-c5b07cf80682

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face