756950
Kenvue Brands LLC — FEI 2214133
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 19, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Summit, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |
| 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 |