551741
Buckeye International Inc — FEI 3001419679
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 14, 2008
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Maryland Heights, MO (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1846 | 21 CFR 211.84(d)(3) | Establish reliability of supplier's C of A |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |