Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-12-12.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Dec 2016 – 12 Dec 2016 | Medical Devices & Rad Health | Clean | |
| 6 May 2013 – 10 May 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Sep 2010 | Not recorded | 483 | View 483 → |
| 29 Sep 2008 | Not recorded | 483 | On file |
| 13 Nov 2006 | Not recorded | Clean | |
| 1 Jul 2003 | Not recorded | Clean | |
| 12 Aug 2002 | Not recorded | Clean | |
| 4 Sep 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 May 2013
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by Janet Pulver, James R Montero
10 May 2013
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Janet Pulver, James R Montero
24 Sep 2010
21 CFR 820.75(c)
Process changes - review, evaluation and revalidation
Cited by James R Montero
24 Sep 2010
21 CFR 820.80(d)
Lack of or inadequate final acceptance procedures
Cited by James R Montero
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 803.50(a)(1) | 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(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(c) | 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 Summit Medical Products, Inc.'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