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FDA Inspection
•Mixie•January 12, 2018

Mixie – FDA Inspection, Jan 12, 2018

Record Details

This FDA Inspection record concerns Mixie, with an inspection on January 12, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Mixie
Inspection Date
January 12, 2018
Product Type
Drugs
Office
Center for Drug Evaluation and Research
People
  • James K. Ireland (FDA Associated Person)
  • Tenzin Jangchup (FDA Associated Person)
View Company Profile

ID · 05b8474e-3446-4939-93eb-e8dc9262e7c7

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1037474
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 211.125(a)Strict control not exercised over labeling issued
  2. 21 CFR 211.22(d)Procedures not in writing, fully followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Mixie

8
DateClassificationOfficeProject area
January 28, 2026NAIMinneapolis District OfficeColors and Cosmetics Technology
June 18, 2025VAIMinneapolis District OfficeDrug Quality Assurance
April 30, 2019Not classifiedMinneapolis District Office
July 6, 2017VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
February 7, 2017NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
View all 8 other inspections on the company page
Other documents for Mixie
  • FDA Inspection 1300154 - 2026-01-28
  • FDA Inspection 1274241 - 2025-06-18
  • FDA Inspection 1088244 - 2019-04-30
  • FDA Inspection 1017493 - 2017-07-06
  • FDA Inspection 1002960 - 2017-02-07

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