# FDA 483 - Geneva Laboratories, Inc - April 05, 2018

Source: https://www.globalkeysolutions.net/records/483/geneva-laboratories-inc/bc2a0704-a10b-4ab4-8e6a-1cf7f7e02b46

> FDA 483 for Geneva Laboratories, Inc on April 05, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Geneva Laboratories, Inc
- Inspection Date: 2018-04-05
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Geneva Laboratories, Inc. in Elkhorn, WI, underwent a GLP BIMO inspection from March 28 to April 5, 2018. The inspection revealed four significant observations related to inadequate equipment validation, insufficient quality assurance unit oversight of nonclinical studies, unqualified personnel signing off on GLP studies, and a lack of independence within the Quality Assurance Unit's reporting structure. These issues indicate deficiencies in the firm's adherence to Good Laboratory Practice regulations.

## Related Documents

- [483 - 2021-06-01](https://www.globalkeysolutions.net/records/483/geneva-laboratories-inc/eb077985-b4f5-4f30-bf0f-9d540d6e5359)
- [483 - 2021-06-03](https://www.globalkeysolutions.net/records/483/geneva-laboratories-inc/29759897-6c95-4fbe-b5d3-1144ad21751a)
- [483 - 2021-07-23](https://www.globalkeysolutions.net/records/483/geneva-laboratories-inc/91bd8eec-5e93-44f0-89f2-9e3547b6abb7)
- [483 - 2025-11-04](https://www.globalkeysolutions.net/records/483/geneva-laboratories-inc/830ea8a6-ef51-4d3a-b94d-f3ac1e7ef6cf)

## Related Officers

- [Bioresearch Monitoring Specialis](https://www.globalkeysolutions.net/people/denise-l-burosh/075a442f-67e0-4a65-9c09-e8819a329773)

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