769705
Chromatography Institute of America — FEI 3012069146
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 21, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Castle Rock, CO (United States)
Citations
| ID | CFR | Description |
|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |