Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-11.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Jun 2026 – 11 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Jul 2014 – 30 Jul 2014 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Jun 2026
ISO 13485:2016 Clause 7.5.6
Process for production and service provision not validated
Cited by Jeffrey J Thibodeau
11 Jun 2026
ISO 13485:2016 Clause 7.5.6
Process for production and service provision not validated
Cited by Jeffrey J Thibodeau
30 Jul 2014
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Jonathan B Lewis
Investigators
FDA investigators tied to this site in the record.
Jeffrey J Thibodeau1 insp.
Jonathan B Lewis1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 7.5.6 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Hi Tech Mold & Tool, Inc.'s 2 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat