Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-02.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Mar 2026 – 2 Apr 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Nov 2018 – 21 Nov 2018 | Medical Devices & Rad Health | Clean | |
| 10 Sep 2014 – 12 Sep 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Sep 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Sep 2014
21 CFR 820.70(a)
Production processes
Cited by Nealie C Newberger, Jeffrey J Thibodeau, Nealie Newberger
12 Sep 2014
21 CFR 820.184
Lack of or inadequate DHR procedures
Cited by Nealie C Newberger, Jeffrey J Thibodeau, Nealie Newberger
Investigators
FDA investigators tied to this site in the record.
Eric C Schmitt2 insp.
Nealie C Newberger1 insp.
Jeffrey J Thibodeau1 insp.
Nealie Newberger1 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 8.5.2 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Gregory Manufacturing, Inc.'s 2 Form 483s
Source PDFs, 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