Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-21.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 May 2026 – 21 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Jul 2014 – 23 Jul 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Apr 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
21 May 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Matthew D Schnittker
23 Jul 2014
21 CFR 820.70(g)(1)
Maintenance schedule, Lack of or inadequate schedule
Cited by Meisha A Mandal
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 801.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | 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 MDI East Inc., DBA Aptyx's 3 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