871561
AgroChem USA, LLC — FEI 3005566735
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 31, 2014
- Fiscal Year
- 2014
- 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 |
| 1168 | 21 CFR 211.34 | Consultant Records |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |