Overview
- 9 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-06.
At a glance
Inspections
9
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Mar 2026 – 6 Apr 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Jan 2023 – 9 Jan 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Dec 2019 – 16 Dec 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Mar 2016 – 14 Mar 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 May 2014 – 3 Jun 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Jan 2012 | Not recorded | 483 | View 483 → |
| 5 Nov 2007 | Not recorded | Clean | |
| 28 Aug 2003 | Not recorded | Clean | |
| 16 Aug 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Apr 2026
ISO 13485:2016 Clause 4.1.5
Control over outsourced processes not proportionate to risk
Cited by Andrew J Garufi
6 Apr 2026
ISO 13485:2016 Clause 4.1.5
Control over outsourced processes not proportionate to risk
Cited by Andrew J Garufi
Investigators
FDA investigators tied to this site in the record.
Andrew J Garufi2 insp.
Preston M Lee1 insp.
Ronald Ifraimov1 insp.
Evelyn Taha1 insp.
Kwong P Lee1 insp.
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 | 4x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.20(b)(3) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 4.1.5 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Vasomedical Inc'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