Overview
- 9 public-safe observations are available for this inspection.
- 9 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.
30 Nov 2012
21 CFR 110.35(a)
Buildings/good repair
Cited by Darren D Holaday, Karen M Labounty, Gregory S Larson
30 Nov 2012
21 CFR 110.35(d)
Failure to clean - general
Cited by Darren D Holaday, Karen M Labounty, Gregory S Larson
30 Nov 2012
21 CFR 110.35(d)(5)
Shown to be effective
Cited by Darren D Holaday, Karen M Labounty, Gregory S Larson
30 Nov 2012
21 CFR 110.37(e)
Running water at suitable temperature
Cited by Darren D Holaday, Karen M Labounty, Gregory S Larson
30 Nov 2012
21 CFR 110.80
Reasonable precautions
Cited by Darren D Holaday, Karen M Labounty, Gregory S Larson
Inspected site
BCBongards' CreameriesPerham, 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(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.35(d)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.37(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.10 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.8(a)(3)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.9(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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