FDA Inspection 655394 — Cerapedics, Inc.
The FDA completed an inspection of Cerapedics, Inc. on April 2, 2010 in Westminster, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 2, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Westminster, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |