Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-01.
At a glance
Inspections
7
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Mar 2026 – 1 Apr 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Aug 2025 | Biologics | Clean | |
| 29 Oct 2018 – 2 Nov 2018 | Medical Devices & Rad Health | 483 | On file |
| 19 Nov 2015 – 8 Dec 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Sep 2015 – 5 Oct 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Nov 2012 | Not recorded | 483 | View 483 → |
| 11 Jun 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Apr 2026
ISO 13485:2016 Clause 7.5.7
Sterilization and sterile barrier system validation procedures not documented
Cited by Sara M Onyango
1 Apr 2026
ISO 13485:2016 Clause 7.5.7
Sterilization and sterile barrier system validation procedures not documented
Cited by Sara M Onyango
8 Dec 2015
21 CFR 812.140(b)(3)
Sponsor records of investigator agreements inadequate
Cited by Matthew C Watson
Investigators
FDA investigators tied to this site in the record.
Sara M Onyango1 insp.
Irina Gaberman1 insp.
MDSAP WilliamsA1 insp.
Matthew C Watson1 insp.
Elizabeth B Griffin1 insp.
Camerson E Moore1 insp.
Darin S Wiegers1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.56 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 806.20(b)(4) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| ISO 13485:2016 Clause 7.5.7 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 812.140(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Arthrosurface, Inc.'s 5 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