Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-06-11.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Jun 2024 – 11 Jun 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 Dec 2017 – 3 Jan 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Mar 2016 – 17 Mar 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Sep 2013 – 11 Sep 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Sep 2011 | Not recorded | Clean | |
| 15 Jun 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Nabil Nakhoul2 insp.
Tamara S Rosbury1 insp.
John A Sciacchitano1 insp.
Philip H Lafleur1 insp.
George T Allen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 1002.10 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1002.13 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1002.20(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1002.30(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1003.21(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1020.30(d)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Medtronic Navigation, Inc.-Boxborough's 4 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