Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-06.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Nov 2025 – 6 Nov 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Jul 2022 – 8 Jul 2022 | Medical Devices & Rad Health | Clean | |
| 26 Nov 2018 | Medical Devices & Rad Health | Clean | |
| 11 Aug 2015 – 27 Aug 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Dec 2012 | Not recorded | Clean | |
| 8 Mar 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Nov 2025
21 CFR 830.300(a)
Devices subject to device identification GUDID data submission requirements.
Cited by Preston M Lee
27 Aug 2015
21 CFR 820.40(a)
Document review, approval by designated individual
Cited by Andrew J Garufi
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 830.300(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Tools For Surgery, LLC'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