Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
1 Oct 2009
21 CFR 110.35(a)
Buildings/good repair
Cited by Matthew R Dionne, Elisa J Beard, Kevin D Kallander
1 Oct 2009
21 CFR 110.35(c)
Lack of effective pest exclusion
Cited by Matthew R Dionne, Elisa J Beard, Kevin D Kallander
1 Oct 2009
21 CFR 110.35(d)(5)
Safe and adequate for use
Cited by Matthew R Dionne, Elisa J Beard, Kevin D Kallander
1 Oct 2009
21 CFR 110.80(b)(1)
Maintenance of equip., utensils, and finished food packaging
Cited by Matthew R Dionne, Elisa J Beard, Kevin D Kallander
1 Oct 2009
21 CFR 110.80(b)(2)
Manufacturing conditions
Cited by Matthew R Dionne, Elisa J Beard, Kevin D Kallander
Inspected site
BDBurrito Del Mar II, LLCBoulder, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 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 110.35(d)(5) | 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 110.80(b)(6) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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