819440
Transtracheal Systems, Inc. — FEI 1721097
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 19, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Englewood, CO (United States)
Citations
| ID | CFR | Description |
|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3270 | 21 CFR 820.80(c) | Documentation |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |