Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-03.
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 |
|---|---|---|---|
| 1 Jun 2026 – 3 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 31 Aug 2021 – 3 Sep 2021 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Jun 2026
ISO 13485:2016 Clause 8.1
Methods for monitoring, measurement, analysis, and improvement not determined
Cited by Suyang Qin
3 Jun 2026
ISO 13485:2016 Clause 8.2.1
Information gathered in feedback process not used as input into risk management
Cited by Suyang Qin
3 Jun 2026
ISO 13485:2016 Clause 8.4
Procedures for analysis of data not documented
Cited by Suyang Qin
3 Sep 2021
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Suyang Qin
Investigators
FDA investigators tied to this site in the record.
Suyang Qin2 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.1 | 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 8.4 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Medartis Inc.'s 2 Form 483s
Source PDFs 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