FDA Inspection 800493 — Fresenius Kabi Oncology Limited
The FDA completed an inspection of Fresenius Kabi Oncology Limited on Aug 28, 2012 in Baddi. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 28, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Baddi (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |