FDA Inspection
Kenvue Brands LLCKenvue Brands LLC – FDA Inspection, Jan 19, 2012
Record Details
This FDA Inspection record concerns Kenvue Brands LLC, with an inspection on January 19, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Kenvue Brands LLC
- Inspection Date
- January 19, 2012
- Product Type
- Devices
View Company Profile
ID · 78665bd2-a775-4b85-b20e-dcc77e584f8c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 756950
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Kenvue Brands LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| August 25, 2023 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| August 2, 2023 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| December 11, 2017 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| July 9, 2015 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 17, 2015 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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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