Overview
- 11 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-10-09.
At a glance
Inspections
11
Form 483s
6
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Sep 2020 – 9 Oct 2020 | Medical Devices & Rad Health | Clean | |
| 8 Aug 2018 – 30 Aug 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Aug 2017 – 25 Aug 2017 | Medical Devices & Rad Health | 483 | On file |
| 29 Nov 2016 – 18 Jan 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Feb 2013 – 1 Mar 2013 | Medical Devices & Rad Health | Clean | |
| 18 Nov 2011 | Not recorded | 483 | View 483 → |
| 14 Dec 2009 | Not recorded | WL | On file |
| 15 Jul 2009 | Not recorded | 483 | On file |
| 19 Mar 2008 | Not recorded | Clean | |
| 21 Dec 2006 | Not recorded | Clean | |
| 15 Nov 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Aug 2018
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Teresa K Kastner, Christina L Bigham
30 Aug 2018
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Teresa K Kastner, Christina L Bigham
30 Aug 2018
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Teresa K Kastner, Christina L Bigham
30 Aug 2018
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Teresa K Kastner, Christina L Bigham
30 Aug 2018
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Teresa K Kastner, Christina L Bigham
Investigators
FDA investigators tied to this site in the record.
Teresa K Kastner3 insp.
Maribeth G Grattan3 insp.
Christina L Bigham2 insp.
MDSAP WilliamsA1 insp.
Cynthia T Cain1 insp.
Laureen M Geniusz1 insp.
Rosanna M Goodrich1 insp.
Javonica F Penn1 insp.
Christine E Kelley1 insp.
R.Terry Bolen1 insp.
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 | 7x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Cincinnati Sub-Zero Products LLC's 6 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