702976
Advanced Sterilization Products — FEI 3003662624
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 17, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 14715 | 21 CFR 820.30(d) | Design output - Lack of or inadequate procedures |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |
| 3230 | 21 CFR 820.70(i) | Validation of changes to automated process software |
| 3343 | 21 CFR 820.198(e) | Maintained |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |
| 743 | 21 CFR 803.52(b)(1) | Identification of Adverse Event or Product Problem |
| 778 | 21 CFR 803.52(f)(1) | Type of Reportable Event |