FDA Inspection
Kenvue Brands LLCKenvue Brands LLC – FDA Inspection, Apr 30, 2010
Record Details
This FDA Inspection record concerns Kenvue Brands LLC, with an inspection on April 30, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Kenvue Brands LLC
- Inspection Date
- April 30, 2010
- Product Type
- Drugs
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ID · 2a0faae4-f94a-46b8-97d3-3926c4fee54b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 660994
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
20- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.84(d)(4)Microscopic Exam of Components
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.110(a)Control procedures fail to include the following
- 21 CFR 211.101(d)Component release checked by 2nd person
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.198(a)Procedures to be written and followed
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Other FDA inspections of Kenvue Brands LLC
12| Date | Classification | Office | Project area |
|---|---|---|---|
| April 8, 2026 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| February 10, 2026 | VAI | Philadelphia District Office | Drug Quality Assurance |
| October 7, 2022 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 3, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 9, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Kenvue Brands LLC
- FDA Inspection 1312770 - 2026-04-08
- FDA Inspection 1298966 - 2026-02-10
- FDA Inspection 1181517 - 2022-10-07
- FDA Inspection 1142303 - 2021-05-03
- FDA Inspection 1005463 - 2016-12-09
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