# FDA 483 - Geneva Laboratories, Inc - July 23, 2021

Source: https://www.globalkeysolutions.net/records/483/geneva-laboratories-inc/91bd8eec-5e93-44f0-89f2-9e3547b6abb7

> FDA 483 for Geneva Laboratories, Inc on July 23, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Geneva Laboratories, Inc
- Inspection Date: 2021-07-23
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Geneva Laboratories, Inc. in Elkhorn, WI, a nonclinical laboratory, revealed multiple deficiencies in their operations. The firm failed to adhere to GLP regulations concerning quality assurance monitoring, personnel training, resource availability, equipment maintenance, and proper archiving of study data. These issues indicate a significant lack of control over critical aspects of nonclinical laboratory studies, potentially compromising data integrity.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/nicole-c-victoria/8c5f8060-452f-4fe5-a43f-a448ec020e60)

Company: https://www.globalkeysolutions.net/companies/geneva-laboratories-inc/f06d802f-33ba-4e22-8fba-667d97ec0721

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d