Overview
- 8 public-safe observations are available for this inspection.
- 6 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.
5 May 2015
21 CFR 113.100(c)(3)
Accuracy record: outside facility, traceability
Cited by Elizabeth P Mayer, Karen M Labounty
5 May 2015
21 CFR 113.100(e)
Records review infrequent / not done
Cited by Elizabeth P Mayer, Karen M Labounty
5 May 2015
21 CFR 113.40(g)(1)(i)(I)
Monitoring of seals and barriers to contamination (S)
Cited by Elizabeth P Mayer, Karen M Labounty
5 May 2015
21 CFR 113.60(a)
Frequency: visual closure examination, qualified person.
Cited by Elizabeth P Mayer, Karen M Labounty
Inspected site
SDSaputo Dairy Foods USA, LLCWhite Bear Lake, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 113.100(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 113.40(g)(1)(i)(I) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 113.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.100(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.60(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.60(a)(3) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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