Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-28.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Aug 2025 – 28 Aug 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Aug 2024 – 14 Aug 2024 | Medical Devices & Rad Health | Clean | |
| 21 Oct 2019 – 24 Oct 2019 | Medical Devices & Rad Health | Clean | |
| 6 Jul 2015 – 9 Jul 2015 | Medical Devices & Rad Health | 483 | On file |
| 25 Mar 2013 – 28 Mar 2013 | Medical Devices & Rad Health | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Aug 2025
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Felix J Marrero
28 Mar 2013
21 CFR 803.17(b)(1)
Info evaluated to determine if event was reportable
Cited by David H Smith
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 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.17(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.180 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Northern Digital Inc.'s 3 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