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FDA Inspection
•Saputo Dairy Foods USA, LLC•September 22, 2015

FDA Inspection 943975 - Saputo Dairy Foods USA, LLC - September 22, 2015

Record Details

This FDA Inspection record concerns Saputo Dairy Foods USA, LLC, with an inspection on September 22, 2015, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Saputo Dairy Foods USA, LLC
Inspection Date
September 22, 2015
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · e20d6143-6498-4d96-81f2-3abdc55f8c16

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
943975
FDA center
Foods & Cosmetics
Project area
Foodborne Biological Hazards

FDA Citations

10
  1. 21 CFR 113.40(g)(4)Critical factors record - frequency
  2. 21 CFR 113.83Critical factors not stated
  3. 21 CFR 113.40(g)(1)(i)(F)Maintain product flow
  4. 21 CFR 113.100(b)Review not timely
  5. 21 CFR 113.40(g)(1)(i)(A)Aseptic processing: reference device, identity, tag, seal
  6. 21 CFR 108.35(c)(3)(i)Process adherence
  7. 21 CFR 113.40(a)(2)(i)Range, chart graduations
  8. 21 CFR 110.40(f)Q.C. instrument accuracy, maintenance
  9. 21 CFR 113.40(g)(2)(ii)(B)Aseptic Processing - Deviations
  10. 21 CFR 113.60(c)Coding - required elements

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Saputo Dairy Foods USA, LLC

6
DateClassificationOfficeProject area
September 28, 2022NAICenter for Food Safety and Applied NutritionTechnical Assistance: Food and Cosmetics
July 24, 2018NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
September 8, 2016NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
February 20, 2014VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
February 22, 2011VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
View all 6 other inspections on the company page
Other documents for Saputo Dairy Foods USA, LLC
  • FDA Inspection 1210256 - 2022-09-28
  • FDA Inspection 1065297 - 2018-07-24
  • FDA Inspection 998530 - 2016-09-08
  • FDA Inspection 868146 - 2014-02-20
  • FDA Inspection 712663 - 2011-02-22

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