# FDA 483 - Vaupell Midwest Molding and Tooling - March 04, 2022

Source: https://www.keypedia.com/records/483/vaupell-midwest-molding-and-tooling/eb3b21a1-8aa6-466f-be81-770133d49805

> FDA 483 for Vaupell Midwest Molding and Tooling on March 04, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Vaupell Midwest Molding and Tooling
- Inspection Date: 2022-03-04
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Vaupell Midwest Molding and Tooling, a medical device manufacturer in Constantine, MI, revealed significant deficiencies in their corrective and preventive action procedures. The firm failed to adequately establish requirements for analyzing quality data to identify causes of nonconforming products or other quality problems. This indicates a lack of robust quality system controls.

## Related Officers

- [David J. Gasparovich](https://www.keypedia.com/people/david-j-gasparovich/478888db-d4b3-481a-89f5-ee234a160f07)

Company: https://www.keypedia.com/companies/vaupell-midwest-molding-and-tooling/a03cf28c-d1f9-430d-acd1-746f9c5647c8

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0