Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-03-31.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Mar 2026 – 31 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Jun 2019 – 24 Jun 2019 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Mar 2026
21 CFR 1010.2(c)
Certification not based on adequate test/testing program
Cited by Frank J Marciniak
Investigators
FDA investigators tied to this site in the record.
Frank J Marciniak1 insp.
William R Chang1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 7.3.7 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1002.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1002.13 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1010.2(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1040.10(g)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1040.11(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.35(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.45(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 830.310(b) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.1.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.2.5 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 5.6.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.6(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind IVIMEA LLC'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