Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-18.
At a glance
Inspections
7
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Sep 2025 – 18 Sep 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Jun 2023 – 16 Aug 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Jan 2022 – 15 Feb 2022 | Medical Devices & Rad Health | WL | View 483 → |
| 5 Dec 2017 – 15 Dec 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Aug 2016 – 11 Aug 2016 | Medical Devices & Rad Health | WL | View 483 → |
| 22 Aug 2012 | Not recorded | 483 | View 483 → |
| 24 Oct 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Aug 2023
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Nabil Nakhoul
Investigators
FDA investigators tied to this site in the record.
Nabil Nakhoul3 insp.
Sara M Onyango1 insp.
Suzanne M Healy1 insp.
Tamara S Rosbury1 insp.
Dawn M Braswell1 insp.
Michael P Sweeney1 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 | 6x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.200(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Zyno Medical LLC's 6 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