Overview
- 8 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2014-06-17.
At a glance
Inspections
8
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Jun 2014 – 17 Jun 2014 | Foods & Cosmetics | 483 | View 483 → |
| 28 Oct 2013 – 1 Nov 2013 | Foods & Cosmetics | 483 | View 483 → |
| 19 Feb 2013 – 14 Mar 2013 | Foods & Cosmetics | 483 | View 483 → |
| 5 Mar 2012 | Not recorded | 483 | View 483 → |
| 6 Oct 2010 | Not recorded | Clean | |
| 5 Apr 2010 | Not recorded | 483 | View 483 → |
| 16 Jun 2009 | Not recorded | 483 | View 483 → |
| 21 Aug 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Jun 2014
21 CFR 110.10(b)(6)
Failure to wear
Cited by Jeffrey N Gerdes, Kristen L Demaio, Kristen L Kamas
17 Jun 2014
21 CFR 110.35(c)
Lack of effective pest exclusion
Cited by Jeffrey N Gerdes, Kristen L Demaio, Kristen L Kamas
17 Jun 2014
21 CFR 110.80(b)(1)
Maintenance of equip., utensils, and finished food packaging
Cited by Jeffrey N Gerdes, Kristen L Demaio, Kristen L Kamas
17 Jun 2014
21 CFR 110.80(b)(7)
Equipment, containers, utensils
Cited by Jeffrey N Gerdes, Kristen L Demaio, Kristen L Kamas
Investigators
FDA investigators tied to this site in the record.
Jeffrey N Gerdes2 insp.
State Agency2 insp.
Kristen L Demaio1 insp.
Kristen L Kamas1 insp.
Lisa A Bowden1 insp.
Lisa A Carpenter1 insp.
Bryce E Mansfield1 insp.
Katherine L Arnold1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 110.40(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 110.80(b)(7) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 110.80(a)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 110.80(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 110.10(b)(6) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.35(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.40(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.20(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(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 111.20(d)(1)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Biofournil of America, Inc.'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