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FDA Inspection
•Kenvue Brands LLC•March 10, 2014

Kenvue Brands LLC – FDA Inspection, Mar 10, 2014

Record Details

This FDA Inspection record concerns Kenvue Brands LLC, with an inspection on March 10, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company
Kenvue Brands LLC
Inspection Date
March 10, 2014
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 7649cefe-a082-4597-b44e-ed941bfce6e2

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
869677
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

3
  1. 21 CFR 820.30(g)Design validation acceptance criteria
  2. 21 CFR 820.100(a)Lack of or inadequate procedures
  3. 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Kenvue Brands LLC

9
DateClassificationOfficeProject area
August 25, 2023NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
August 2, 2023NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
December 11, 2017VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
July 9, 2015VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
June 17, 2015VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
View all 9 other inspections on the company page
Other documents for Kenvue Brands LLC
  • FDA Inspection 1216785 - 2023-08-25
  • FDA Inspection 1216421 - 2023-08-02
  • FDA Inspection 1034479 - 2017-12-11
  • FDA Inspection 932444 - 2015-07-09
  • FDA Inspection 930475 - 2015-06-17

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