Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-06-18.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jun 2026 – 18 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Jun 2026
ISO 13485:2016 Clause 5.6.2
Input to management review is incomplete
Cited by Ronald Ifraimov
18 Jun 2026
ISO 13485:2016 Clause 8.2.1
Information gathered in feedback process not used as input into risk management
Cited by Ronald Ifraimov
18 Jun 2026
ISO 13485:2016 Clause 8.2.2
Complaint handling records not maintained
Cited by Ronald Ifraimov
Investigators
FDA investigators tied to this site in the record.
Ronald Ifraimov1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(d) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 5.6.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind INSPIREMD Inc's 1 Form 483
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