FDA Inspection 943975 — Saputo Dairy Foods USA, LLC
The FDA completed an inspection of Saputo Dairy Foods USA, LLC on September 22, 2015 in Frederick, MD. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 22, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Frederick, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 1472 | 21 CFR 113.83 | Critical factors not stated |
| 1641 | 21 CFR 113.100(b) | Review not timely |
| 16456 | 21 CFR 113.40(g)(1)(i)(A) | Aseptic processing: reference device, identity, tag, seal |
| 16482 | 21 CFR 113.40(g)(2)(ii)(B) | Aseptic Processing - Deviations |
| 1732 | 21 CFR 113.40(a)(2)(i) | Range, chart graduations |
| 2837 | 21 CFR 113.40(g)(4) | Critical factors record - frequency |
| 2859 | 21 CFR 113.40(g)(1)(i)(F) | Maintain product flow |
| 3877 | 21 CFR 113.60(c) | Coding - required elements |
| 4519 | 21 CFR 108.35(c)(3)(i) | Process adherence |