699572
Osteotech, Inc. — FEI 3002600221
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 9, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Eatontown, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 12323 | 21 CFR 1271.160(b)(5) | Monitoring systems |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12351 | 21 CFR 1271.190(d)(1) | Procedures for cleaning, sanitation |
| 12387 | 21 CFR 1271.220(a) | Causing contamination, increasing risks |
| 12405 | 21 CFR 1271.250(a) | Controlling the labeling of HCT/Ps |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |