Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-08-12.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Aug 2016 – 12 Aug 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 Jan 2015 – 15 Jan 2015 | Medical Devices & Rad Health | WL | View 483 → |
| 25 May 2011 | Not recorded | 483 | On file |
| 29 Sep 2009 | Not recorded | 483 | View 483 → |
| 13 Jan 2006 | Not recorded | Clean | |
| 14 Feb 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Aug 2016
21 CFR 806.10(a)(1)
Report of risk to health
Cited by Joshua J Silvestri, Phillip M Pontikos
12 Aug 2016
21 CFR 806.10(a)(1)
Report of risk to health
Cited by Joshua J Silvestri, Phillip M Pontikos
12 Aug 2016
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Joshua J Silvestri, Phillip M Pontikos
12 Aug 2016
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Joshua J Silvestri, Phillip M Pontikos
12 Aug 2016
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Joshua J Silvestri, Phillip M Pontikos
Investigators
FDA investigators tied to this site in the record.
Phillip M Pontikos2 insp.
Bill Tackett2 insp.
Joshua J Silvestri1 insp.
Melanie W Pishnery1 insp.
Robert D Tollefsen1 insp.
Melanie G Warzala1 insp.
Joan A Loreng1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.20(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | 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 Soft Computer Consultants, Inc.'s 4 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