663879
Bullet Line LLC — FEI 3005625923
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 8, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Florence, KY (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2001 | 21 CFR 211.184(b) | Component Test Records |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |