FDA Inspection 545672 — CeraSys Incorporated
The FDA completed an inspection of CeraSys Incorporated on October 29, 2008 in La Mirada, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 29, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- La Mirada, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 4058 | 21 CFR 820.20 | Management responsibility |
| 4189 | 21 CFR 820.198(a) | General |
| 538 | 21 CFR 820.70(a) | Process control procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |