Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-04-22.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Apr 2015 – 22 Apr 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 Sep 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Apr 2015
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Ronald Ifraimov
22 Apr 2015
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Ronald Ifraimov
27 Sep 2012
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by Melissa I Michurski
27 Sep 2012
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Melissa I Michurski
Investigators
FDA investigators tied to this site in the record.
Ronald Ifraimov1 insp.
Melissa I Michurski1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 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 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Icare Finland Oy'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