FDA Inspection 827048 — Kenvue Brands LLC
The FDA completed an inspection of Kenvue Brands LLC on Apr 10, 2013 in Summit, NJ. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 10, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Summit, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |