Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-17.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Apr 2026 – 17 Apr 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Oct 2022 – 27 Oct 2022 | Medical Devices & Rad Health | Clean | |
| 14 Jan 2020 – 16 Jan 2020 | Medical Devices & Rad Health | Clean | |
| 7 Nov 2016 – 15 Nov 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 Jul 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Apr 2026
ISO 13485:2016 Clause 7.1
Records of risk management activities in product realization not maintained
Cited by Rosanna M Goodrich
17 Apr 2026
ISO 13485:2016 Clause 7.4.1
Supplier monitoring and re-evaluation not planned
Cited by Rosanna M Goodrich
15 Nov 2016
21 CFR 803.17(a)(3)
Lack of System for Timely Submission of Reports
Cited by Cynthia T Cain
15 Nov 2016
21 CFR 803.17(a)(3)
Lack of System for Timely Submission of Reports
Cited by Cynthia T Cain
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 803.17(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Norwood Medical, LLC'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