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FDA Inspection
•Ito En (USA) Inc•July 2, 2012

Ito En (USA) Inc – FDA Inspection, Jul 2, 2012

Record Details

This FDA Inspection record concerns Ito En (USA) Inc, with an inspection on July 2, 2012, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Ito En (USA) Inc
Inspection Date
July 2, 2012
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · ee92f1b0-dd21-412a-9346-82aa02892d6d

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
788702
FDA center
Foods & Cosmetics
Project area
Foodborne Biological Hazards

FDA Citations

13
  1. 21 CFR 113.60(b)Cooling water - not chlorinated, sanitized
  2. 21 CFR 110.35(d)Failure to clean - general
  3. 21 CFR 113.89Evaluation by process authority
  4. 21 CFR 113.40(b)(8)Drain valve
  5. 21 CFR 110.35(a)Buildings/good repair
  6. 21 CFR 108.35(c)(3)(i)Process adherence
  7. 21 CFR 108.35(c)(3)(ii)Process information availability
  8. 21 CFR 108.35(c)(2)(ii)Process change recording
  9. 21 CFR 113.87(b)Visual indicators not used
  10. 21 CFR 110.40(d)Holding, conveying, mfg systems - design & construction

Showing 10 of 13 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Ito En (USA) Inc

5
DateClassificationOfficeProject area
May 13, 2025NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
October 6, 2017VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
April 28, 2015NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
August 23, 2013VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
March 16, 2009VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
Other documents for Ito En (USA) Inc
  • FDA Inspection 1272364 - 2025-05-13
  • FDA Inspection 1027985 - 2017-10-06
  • FDA Inspection 926295 - 2015-04-28
  • FDA Inspection 845192 - 2013-08-23
  • FDA Inspection 575716 - 2009-03-16

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