Overview
- 15 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-02-17.
At a glance
Inspections
15
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Feb 2018 | Foods & Cosmetics | 483 | On file |
| 27 Apr 2017 | Foods & Cosmetics | Clean | |
| 16 Nov 2014 – 17 Nov 2014 | Foods & Cosmetics | 483 | On file |
| 8 Sep 2013 – 9 Sep 2013 | Foods & Cosmetics | 483 | On file |
| 11 Jun 2012 | Not recorded | 483 | View 483 → |
| 20 Mar 2011 | Not recorded | Clean | |
| 29 Mar 2010 | Not recorded | 483 | On file |
| 22 Jun 2009 | Not recorded | 483 | On file |
| 3 Nov 2008 | Not recorded | 483 | On file |
| 11 Dec 2007 | Not recorded | Clean | |
| 3 Nov 2007 | Not recorded | Clean | |
| 24 Jul 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Jun 2012
21 CFR 1250.33(a)
Easily cleaned, self-draining
Cited by Julia E Chervoni, John Cook, Wendy S Shenk
11 Jun 2012
21 CFR 1250.35(b)
Open lesion or infected wound
Cited by Julia E Chervoni, John Cook, Wendy S Shenk
11 Jun 2012
21 CFR 1250.38(b)
Soap, sanitary towels, water
Cited by Julia E Chervoni, John Cook, Wendy S Shenk
Investigators
FDA investigators tied to this site in the record.
Craig K Hopkins4 insp.
Julia E Chervoni3 insp.
Janice K Gardner3 insp.
Stuart Kim2 insp.
Wendy S Shenk2 insp.
John Cook1 insp.
Joyce T Mayekawa1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1250.27 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1250.33(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1250.35(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1250.38(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind NCL America LLC's 7 Form 483s
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