FDA Inspection 777303 — ThyssenKrupp Access Corp
The FDA completed an inspection of ThyssenKrupp Access Corp on April 10, 2012 in Grandview, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 10, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Grandview, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |