Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2012-09-21.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Sep 2012 | Not recorded | 483 | View 483 → |
| 16 Sep 2010 | Not recorded | 483 | View 483 → |
| 20 Aug 2009 | Not recorded | 483 | View 483 → |
| 23 Sep 2008 | Not recorded | 483 | On file |
| 27 Jul 2007 | Not recorded | Clean | |
| 31 Aug 2006 | Not recorded | Clean | |
| 26 Aug 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Jonathan T Little2 insp.
Nancy E Doyle2 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 113.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.16 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.8(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.8(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.8(a)(3)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Winchester Bay Fisheries, LLC.'s 4 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