FDA Inspection 778373 — Kimberly-Clark Corporation
The FDA completed an inspection of Kimberly-Clark Corporation on June 8, 2012 in Neenah, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 8, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Neenah, WI (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 |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |