FDA Inspection 1321566 — Hi Tech Mold & Tool, Inc.
The FDA completed an inspection of Hi Tech Mold & Tool, Inc. on June 11, 2026 in Pittsfield, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 11, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pittsfield, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |