Overview
- 15 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-01-22.
At a glance
Inspections
15
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Jan 2016 – 22 Jan 2016 | Foods & Cosmetics | Clean | |
| 6 Jul 2015 – 31 Jul 2015 | Foods & Cosmetics | 483 | View 483 → |
| 4 Dec 2012 | Not recorded | Clean | |
| 29 Aug 2012 | Not recorded | 483 | View 483 → |
| 9 Feb 2011 | Not recorded | Clean | |
| 29 Oct 2009 | Not recorded | Clean | |
| 21 Jul 2009 | Not recorded | Clean | |
| 30 Apr 2009 | Not recorded | 483 | View 483 → |
| 8 Jul 2008 | Not recorded | Clean | |
| 11 Mar 2008 | Not recorded | 483 | On file |
| 13 Feb 2008 | Not recorded | 483 | On file |
| 9 Mar 2007 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Aug 2012
21 CFR 110.35(e)
Storage of cleaned portable equipment (S)
Cited by Scott W Fox, Julia E Chervoni
Investigators
FDA investigators tied to this site in the record.
Scott W Fox2 insp.
Ian J Thomson2 insp.
Jonathan T Little2 insp.
Brenda K Alford2 insp.
Tara M Pianko1 insp.
Kimberly J Proctor Jones1 insp.
Margo C Jones1 insp.
State Agency1 insp.
Julia E Chervoni1 insp.
Jonathan R Ormond1 insp.
Margo.C.L. Jones1 insp.
Rita E Luttrell1 insp.
Stephen R Souza1 insp.
Shelagh D Schopen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(c)(5) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Gretchens Shoebox Express' 5 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