Overview
- 7 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
27 Jan 2009
21 CFR 110.10(b)(3)
Not washed/sanitized when appropriate
Cited by Steven C Madzo, Holly L Sebastian
27 Jan 2009
21 CFR 110.10(b)(9)
Precautions against contamination--micro, foreign substances
Cited by Steven C Madzo, Holly L Sebastian
27 Jan 2009
21 CFR 110.35(a)
Cleaning and sanitizing operations
Cited by Steven C Madzo, Holly L Sebastian
27 Jan 2009
21 CFR 110.35(c)
Lack of effective pest exclusion
Cited by Steven C Madzo, Holly L Sebastian
Inspected site
DTDenver Tofu Company, IncorporatedDenver, United States
Inspection team
HLHolly L Sebastian
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 110.10(b)(3) | 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)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(c) | 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)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 observations
Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere