Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-04-23.
At a glance
Inspections
5
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Apr 2018 – 23 Apr 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Jul 2017 – 1 Aug 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Jan 2016 – 3 Feb 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Jul 2013 – 6 Aug 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Jul 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Apr 2018
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Kathleen S Tormey, Matthew M Vernon
23 Apr 2018
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Kathleen S Tormey, Matthew M Vernon
23 Apr 2018
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by Kathleen S Tormey, Matthew M Vernon
23 Apr 2018
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by Kathleen S Tormey, Matthew M Vernon
23 Apr 2018
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Kathleen S Tormey, Matthew M Vernon
Investigators
FDA investigators tied to this site in the record.
Kathleen S Tormey2 insp.
Matthew M Vernon2 insp.
Amanda S Zorn2 insp.
Ashleigh P Wodushek1 insp.
Janet Pulver1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.200(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind CME America, LLC'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