FDA Inspection 664164 — Laboratoria Qualiphar NV
The FDA completed an inspection of Laboratoria Qualiphar NV on May 7, 2010 in Bornem. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 7, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bornem (Belgium)
Citations
| ID | CFR | Description |
|---|---|---|
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1977 | 21 CFR 211.182 | Dedicated equipment: records part of batch record |
| 2005 | 21 CFR 211.184(e) | Records of disposition of rejected material |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4370 | 21 CFR 211.188(b)(10) | Records of any sampling performed |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |