# FDA 483 - Vonco Products, Inc. - April 10, 2025

Source: https://www.globalkeysolutions.net/records/483/vonco-products-inc/9098da6a-4621-4c78-afd0-9e36cafbea41

> FDA 483 for Vonco Products, Inc. on April 10, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vonco Products, Inc.
- Inspection Date: 2025-04-10
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Vonco Products, Inc. in Trevor, WI, a medical device manufacturer, received a Form FDA 483 with four observations following an inspection. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning procedures for controlling nonconforming product, process validation, design change, and design input for their Class II EnteraLoc Flow Spouted Pouches. These issues indicate a lack of adequate controls to ensure product quality and compliance with regulatory requirements.

## Related Officers

- [Chad E. Schmear](https://www.globalkeysolutions.net/people/chad-e-schmear/275a4c57-d288-46f9-8257-64fcd96159ce)

Company: https://www.globalkeysolutions.net/companies/vonco-products-inc/fb16833e-b4b9-4d06-81d0-b597853d548e

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