Saputo Dairy Foods USA, LLC FDA Inspection Record
Saputo Dairy Foods USA, LLC is an FDA-inspected facility (FEI 2112421) located in White Bear Lake, MN, US. RegDataLab tracks 6 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- May 1, 2025: No Action Indicated (NAI)
- Inspections on record
- 6 (5 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- 1 listed by FDA for this FEI, latest Feb 4, 2009
- Recalls as the recalling firm
- 1, latest Mar 12, 2008
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 1, 2025 | No Action Indicated (NAI) | No citations listed |
| Mar 6, 2020 | Voluntary Action Indicated (VAI) | Differential pressure recorder-controller, chart (21 CFR 113.40(g)(1)(i)(E)) Stop packaging, ensure segregation (21 CFR 113.40(g)(2)(ii)(B)) Closures other than double seams and glass (21 CFR 113.60(a)(3)) |
| May 5, 2015 | Voluntary Action Indicated (VAI) | Accuracy record: outside facility, traceability (21 CFR 113.100(c)(3)) Review not signed/dated (21 CFR 113.100(b)) Insufficient frequency of management review (21 CFR 113.100(e)) Operator monitor seals, barriers (S) (21 CFR 113.40(g)(1)(i)(I)) and 2 more |
| Jan 31, 2013 | Voluntary Action Indicated (VAI) | Evaluation by process authority (21 CFR 113.89) Manufacturing conditions (21 CFR 110.80(b)(2)) Adjusted to agree with TID (21 CFR 113.40(g)(1)(i)(B)(3)) Closures other than double seams and glass (21 CFR 113.60(a)(3)) and 1 more |
| Aug 22, 2011 | Voluntary Action Indicated (VAI) | Methods of process deviation evaluation (21 CFR 113.89) Critical factors - no record (21 CFR 113.100(a)) |
| Sep 21, 2010 | Voluntary Action Indicated (VAI) | Q.C. instrument accuracy, maintenance (21 CFR 110.40(f)) Process records - forms missing information (21 CFR 113.100(a)) Process deviation log/file (21 CFR 113.89) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Mar 12, 2008 | Class II | F-320-8 | GFS Ultra-Pasteruized Non-Dairy Creamer, Product # 8881574, 464 3/8 Fl. Oz. containers per… Individual cups in the bulk cases may be labeled as Half & Half Creamer but actually contain Non-Dairy Creamer, which contains soy lecithin. |
Facility details
- Company
- Saputo Dairy Foods USA, LLC
- Location
- White Bear Lake, MN (US)
- Source
- inspections