# FDA 483 - Geneva Laboratories, Inc - November 04, 2025

Source: https://www.globalkeysolutions.net/records/483/geneva-laboratories-inc/830ea8a6-ef51-4d3a-b94d-f3ac1e7ef6cf

> FDA 483 for Geneva Laboratories, Inc on November 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Geneva Laboratories, Inc
- Inspection Date: 2025-11-04
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Geneva Laboratories, Inc. in Elkhorn, WI, a contract testing laboratory, was cited for three observations during an FDA inspection. The firm failed to follow quality control unit procedures for out-of-specification results and resampling, used inadequately designed and qualified stability chambers with numerous environmental excursions, and lacked appropriate computer controls to prevent unauthorized editing of raw electronic data. These issues indicate significant deficiencies in quality system management and data integrity.

## Related Documents

- [483 - 2018-04-05](https://www.globalkeysolutions.net/records/483/geneva-laboratories-inc/bc2a0704-a10b-4ab4-8e6a-1cf7f7e02b46)
- [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)

## Related Officers

- [Tyler M. Peterson](https://www.globalkeysolutions.net/people/tyler-m-peterson/207310ee-260c-4618-a515-9895a56e2ede)
- [Research Specialist II](https://www.globalkeysolutions.net/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)

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