1029741
AgroChem USA, LLC — FEI 3005566735
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 25, 2017
- Fiscal Year
- 2018
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Saratoga Springs, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 21297 | 21 CFR 211.186(a) | Master production and control records, procedure |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4383 | 21 CFR 211.198(b)(1) | Written complaint record must include |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |