682164
Straight Arrow Products, Inc. — FEI 2244008
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 23, 2010
- Fiscal Year
- 2010
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Bethlehem, PA (United States)
Citations
| ID | CFR | Description |
|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1251 | 21 CFR 211.42(c)(1) | Incoming material area |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1824 | 21 CFR 211.84(c)(5) | Identifying Sample Containers |
| 1825 | 21 CFR 211.84(c)(6) | Identifying Containers Sampled |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2200 | 21 CFR 211.186(b)(4) | Variation in the Amount of Components Used |
| 2203 | 21 CFR 211.186(b)(7) | Theoretical Yield and Percentages |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |