# FDA 483 - Hi Tech Mold & Tool, Inc. - June 11, 2026

Source: https://www.keypedia.com/records/483/hi-tech-mold-tool-inc/7b190392-b4e9-45af-ab4e-a0dbc73a94ff

> FDA 483 for Hi Tech Mold & Tool, Inc. on June 11, 2026. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Hi Tech Mold & Tool, Inc.
- Inspection Date: 2026-06-11
- Product Type: device
- Office Name: New England District Office
- Summary: Hi Tech Mold & Tool, Inc. in Pittsfield, MA, a medical device manufacturer, received a Form FDA 483 for significant deficiencies in process validation. The firm failed to validate production processes for multiple product codes and manufacturing equipment, and a performance qualification did not meet established targets. These issues indicate a lack of adequate control over critical manufacturing processes.

## 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/hi-tech-mold-tool-inc/37895959-341f-4ec8-8b30-d8bd2c307533

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144