FDA Inspection 709427 — Cranial Solutions
The FDA completed an inspection of Cranial Solutions on January 21, 2011 in Pompton Lakes, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 21, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pompton Lakes, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |