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.
12 Oct 2010
21 CFR 110.10(b)(3)
Not washed/sanitized when appropriate
Cited by Edith M Gonzalez, Jennifer A Baker
12 Oct 2010
21 CFR 110.35(a)
Cleaning and sanitizing operations
Cited by Edith M Gonzalez, Jennifer A Baker
Inspected site
BMBlue Moose of Boulder, LLCLafayette, United States
Inspection team
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 110.35(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 110.37(e)(3) | 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(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(5) | 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