FDA Inspection 768492 — Pacific Consolidated Industries LLC
The FDA completed an inspection of Pacific Consolidated Industries LLC on February 13, 2012 in Riverside, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 13, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Riverside, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14711 | 21 CFR 820.160(a) | Lack of or inadequate procedures for distribution |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |
| 537 | 21 CFR 820.70(a) | Production processes |
| 793 | 21 CFR 803.53(a) | Failure to Submit 5 Day Report |