# FDA 483 - UFP Technologies, Inc. - August 17, 2022

Source: https://www.keypedia.com/records/483/ufp-technologies-inc/a0d6f527-a0c6-41d1-ab4e-6eefc9a81780

> FDA 483 for UFP Technologies, Inc. on August 17, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: UFP Technologies, Inc.
- Inspection Date: 2022-08-17
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: UFF Technologies, Inc. in Chicopee, MA, a contract manufacturer of Class II medical devices, was inspected by the FDA from August 4-17, 2022. The inspection revealed significant issues related to environmental controls in cleanrooms, inadequate documentation of process validation activities, and deficiencies in maintaining customer complaint files. These findings indicate a need for improved quality system procedures to prevent contamination and ensure product quality.

## Related Officers

- [Eric C. Schmitt](https://www.keypedia.com/people/eric-c-schmitt/f2716c8c-f06e-4519-a1e7-63a3ef6e07fb)

Company: https://www.keypedia.com/companies/ufp-technologies-inc/b0213488-7784-4796-bf6d-7b9f06f4228e

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