1027015
BODE Chemie GmbH — FEI 3004007328
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 29, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hamburg (Germany)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1223 | 21 CFR 211.67(b)(5) | Cleaning SOPs/equipment protection |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4345 | 21 CFR 211.160(b)(1) | Samples (various types) representative, identified properly |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |