Overview
- 10 public-safe observations are available for this inspection.
- 8 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.
4 Mar 2015
21 CFR 110.40(f)
Q.C. instrument accuracy, maintenance
Cited by Helen J Hamaoka, Jessica B Darneille
4 Mar 2015
21 CFR 113.100(a)
Process records - forms missing information
Cited by Helen J Hamaoka, Jessica B Darneille
Inspected site
SDSaputo Dairy Foods USA, LLCGustine, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 113.40(g)(1)(i)(A) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 108.35(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.40(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 110.80 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.100(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.60(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.87(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 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