# FDA 483 - GenTrac, Inc. - July 30, 2025

Source: https://www.globalkeysolutions.net/records/483/gentrac-inc/8f80b7fb-ed45-48c5-9adb-a86ea8d9c8f1

> FDA 483 for GenTrac, Inc. on July 30, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GenTrac, Inc.
- Inspection Date: 2025-07-30
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: GenTrac, Inc., a drug substance manufacturer in Middleton, WI, was cited for four observations during an FDA inspection. The findings include uncharacterized residues on equipment surfaces, inadequate microbiological recovery studies for cleaning validation, deficiencies in laboratory training and data management, and a lack of segregation of duties within the Quality Unit. These issues collectively indicate significant concerns regarding quality control, data integrity, and personnel training.

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## Related Officers

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Company: https://www.globalkeysolutions.net/companies/gentrac-inc/6649d47e-f060-44e5-9c19-488234df324f

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