856647
Lumene Oy — FEI 3003908435
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 29, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Espoo (Finland)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1163 | 21 CFR 211.28(b) | Habits of good sanitation & health |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3554 | 21 CFR 211.48(a) | Potable water standards not met |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3562 | 21 CFR 211.56(c) | Written procedures lacking for use of pesticides etc. |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |