Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-27.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Feb 2026 – 27 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Jul 2019 – 2 Aug 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Jul 2019 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Mar 2026
ISO 13485:2016 Clause 4.1.2
Risk-based approach not applied to QMS processes
Cited by Jocelyn C Turner
27 Mar 2026
ISO 13485:2016 Clause 5.6.3
Management review output records lack input reviewed, decisions, and actions
Cited by Jocelyn C Turner
27 Mar 2026
ISO 13485:2016 Clause 7.3.1
Design and development procedures not documented
Cited by Jocelyn C Turner
27 Mar 2026
ISO 13485:2016 Clause 7.4.1
Supplier monitoring and re-evaluation not planned
Cited by Jocelyn C Turner
Investigators
FDA investigators tied to this site in the record.
Ellen J Tave2 insp.
Jocelyn C Turner1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.120 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 4.1.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 5.6.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.1 | 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 7.5.6 | 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 Medical Informatics Corp.'s 2 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