FDA Inspection 838816 — Cranial Technologies, Inc
The FDA completed an inspection of Cranial Technologies, Inc on Jun 5, 2013 in Chandler, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 5, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chandler, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |