579393
Carlsbad Technology, Inc — FEI 1000135190
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 24, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carlsbad, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1768 | 21 CFR 211.137(b) | Storage conditions |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 4576 | 21 CFR 211.192 | No written record of investigation |