# FDA 483 - Vaupell Molding and Tooling, Inc. - March 06, 2020

Source: https://www.keypedia.com/records/483/vaupell-molding-and-tooling-inc/1e30738f-7cb9-469a-9f6f-dd261e0a16be

> FDA 483 for Vaupell Molding and Tooling, Inc. on March 06, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vaupell Molding and Tooling, Inc.
- Inspection Date: 2020-03-06
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Vaupell Molding and Tooling, Inc. in Agawam, MA, a medical device contract manufacturer, was cited with two observations during an FDA inspection. The inspection revealed deficiencies in the firm's process validation activities, which were not documented or approved for a Class II medical device accessory. Additionally, process control procedures were found to be inadequately established, lacking proper identification of part numbers and assembly instructions for the medical device accessory.

## Related Officers

- [Power Trader/Data Scientist](https://www.keypedia.com/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

Company: https://www.keypedia.com/companies/vaupell-molding-and-tooling-inc/6296bf47-0cb6-45a5-aa6a-0f2500fcdfeb

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94