Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-06-22.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Jun 2015 – 22 Jun 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Feb 2011 | Not recorded | 483 | View 483 → |
| 6 Nov 2009 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Jun 2015
21 CFR 820.181
DMR - not or inadequately maintained
Cited by Erin L Mcfiren, Marc S Neubauer
22 Jun 2015
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Erin L Mcfiren, Marc S Neubauer
22 Jun 2015
21 CFR 820.30(g)
Design validation - software validation not performed
Cited by Erin L Mcfiren, Marc S Neubauer
22 Jun 2015
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Erin L Mcfiren, Marc S Neubauer
22 Jun 2015
21 CFR 820.80(b)
Lack of or inadequate receiving acceptance procedures
Cited by Erin L Mcfiren, Marc S Neubauer
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 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.86 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind 3CPM Company, 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