Overview
- 9 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-08-30.
At a glance
Inspections
9
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Aug 2023 – 30 Aug 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 10 Jul 2018 – 11 Jul 2018 | Medical Devices & Rad Health | Clean | |
| 20 Jun 2016 – 24 Jun 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Mar 2013 – 12 Mar 2013 | Medical Devices & Rad Health | Clean | |
| 27 Jan 2012 | Not recorded | Clean | |
| 9 Feb 2010 | Not recorded | 483 | View 483 → |
| 9 Dec 2008 | Not recorded | Clean | |
| 7 Apr 2004 | Not recorded | Clean | |
| 28 Feb 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Aug 2023
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Suyang Qin, Melina L Rodriguez-Upton
30 Aug 2023
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Suyang Qin, Melina L Rodriguez-Upton
30 Aug 2023
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Suyang Qin, Melina L Rodriguez-Upton
Investigators
FDA investigators tied to this site in the record.
Karen L Kosar2 insp.
Suyang Qin1 insp.
Melina L Rodriguez-Upton1 insp.
Amy S Graf1 insp.
Sargum C Sood1 insp.
Marc S Neubauer1 insp.
Kimberley A Ricketts1 insp.
Michael W Burd1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 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 |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SunMed Holdings, LLC'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