FDA Inspection
Hi Tech Mold & Tool, Inc.Hi Tech Mold & Tool, Inc. – FDA Inspection, Jun 11, 2026
Record Details
This FDA Inspection record concerns Hi Tech Mold & Tool, Inc., with an inspection on June 11, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c927cf53-fa13-4501-a89d-e966c08d701d
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1321566
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- ISO 13485:2016 Clause 7.5.8Process for production and service provision not validated
- ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated
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Other FDA inspections of Hi Tech Mold & Tool, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 30, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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