Overview
- 15 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-09-23.
At a glance
Inspections
15
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Sep 2021 – 23 Sep 2021 | Foods & Cosmetics | Clean | |
| 9 Jul 2018 – 12 Jul 2018 | Foods & Cosmetics | Clean | |
| 6 Dec 2016 – 12 Dec 2016 | Foods & Cosmetics | Clean | |
| 7 Jul 2015 – 8 Jul 2015 | Foods & Cosmetics | Clean | |
| 30 May 2012 | Not recorded | 483 | View 483 → |
| 19 Jul 2011 | Not recorded | Clean | |
| 13 Jul 2011 | Not recorded | 483 | View 483 → |
| 10 Jun 2010 | Not recorded | WL | View 483 → |
| 15 May 2009 | Not recorded | Clean | |
| 13 Nov 2008 | Not recorded | 483 | View 483 → |
| 15 Sep 2005 | Not recorded | Clean | |
| 2 Aug 2004 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
30 May 2012
21 CFR 110.35(b)(1)
Safe and adequate for use
Cited by Estefania Fernandez, Cindy W Lewis, Mabel M Lee
30 May 2012
21 CFR 110.80
Supervisory competence
Cited by Estefania Fernandez, Cindy W Lewis, Mabel M Lee
13 Jul 2011
21 CFR 110.35(a)
Cleaning and sanitizing operations
Cited by Cindy W Lewis, Lija V Fellows, Mabel M Lee, Ingrid A Zambrana
13 Jul 2011
21 CFR 110.40(f)
Q.C. instrument accuracy, maintenance
Cited by Cindy W Lewis, Lija V Fellows, Mabel M Lee, Ingrid A Zambrana
Investigators
FDA investigators tied to this site in the record.
Mabel M Lee4 insp.
Cindy W Lewis3 insp.
Lija V Fellows2 insp.
Ronald P Boyce2 insp.
Nianna C Burns1 insp.
Travelle D Mason1 insp.
Victoria L Morgan1 insp.
Brian R Henderson1 insp.
Emal Wahab1 insp.
Chloe-Anne Leong1 insp.
Andrew E Kay1 insp.
Estefania Fernandez1 insp.
Ingrid A Zambrana1 insp.
Roberto Macina1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.80 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(10) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Fresh Express Incorporated'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