# FDA 483 - Geneva Laboratories, Inc - June 01, 2021

Source: https://www.keypedia.com/records/483/geneva-laboratories-inc/eb077985-b4f5-4f30-bf0f-9d540d6e5359

> FDA 483 for Geneva Laboratories, Inc on June 01, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Geneva Laboratories, Inc
- Inspection Date: 2021-06-01
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Genesis Laboratories, Inc, a contract laboratory in Elkhorn, WI, was inspected from June 1-3, 2021. The inspection revealed significant issues with test method validation and data integrity, specifically concerning computer system controls and protection of electronic records. These findings indicate serious deficiencies in quality control and data management practices.

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## Related Officers

- [Gregory R. Brinsley](https://www.keypedia.com/people/gregory-r-brinsley/4e0e1cf0-11c3-4440-bd40-d59fd648ef78)
- [CARL A. STOFERNACK, CSO](https://www.keypedia.com/people/carl-a-stofernack-cso/d4e71259-5e13-43ed-8439-3dfa7b3808fe)

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

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