Overview
- 13 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2011-01-11.
At a glance
Inspections
13
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Jan 2011 | Not recorded | 483 | On file |
| 25 May 2010 | Not recorded | 483 | View 483 → |
| 27 Jan 2009 | Not recorded | 483 | View 483 → |
| 1 Feb 2008 | Not recorded | 483 | On file |
| 13 Apr 2007 | Not recorded | Clean | |
| 2 Jun 2006 | Not recorded | Clean | |
| 27 Jun 2005 | Not recorded | Clean | |
| 1 Jun 2004 | Not recorded | Clean | |
| 15 Nov 2002 | Not recorded | Clean | |
| 7 May 2002 | Not recorded | Clean | |
| 29 Mar 2001 | Not recorded | Clean | |
| 13 Jul 2000 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
25 May 2010
21 CFR 110.10(b)(3)
Not washed/sanitized when appropriate
Cited by Zachery L Miller, Holly L Sebastian, Kevin D Kallander
25 May 2010
21 CFR 110.10(b)(5)
Glove condition
Cited by Zachery L Miller, Holly L Sebastian, Kevin D Kallander
25 May 2010
21 CFR 110.20(b)(4)
Drip and condensate
Cited by Zachery L Miller, Holly L Sebastian, Kevin D Kallander
25 May 2010
21 CFR 110.20(b)(5)
Safety lighting and glass
Cited by Zachery L Miller, Holly L Sebastian, Kevin D Kallander
25 May 2010
21 CFR 110.35(c)
Lack of effective pest exclusion
Cited by Zachery L Miller, Holly L Sebastian, Kevin D Kallander
Investigators
FDA investigators tied to this site in the record.
Holly L Sebastian2 insp.
State Agency1 insp.
Zachery L Miller1 insp.
Kevin D Kallander1 insp.
Steven C Madzo1 insp.
Andrew M Kolenc1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.10(b)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.35(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 110.10(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.10(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.20(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.93 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Denver Tofu Company, 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