605506
Hawthorne Products, Inc — FEI 1824900
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 17, 2009
- Fiscal Year
- 2009
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Dunkirk, IN (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1546 | 21 CFR 211.125(d) | Destruction of excess labels with lot numbers |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2001 | 21 CFR 211.184(b) | Component Test Records |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 2197 | 21 CFR 211.186(b)(2) | Active Ingredient Name and Weight |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4317 | 21 CFR 211.84(d)(3) | Certificates of Testing (Containers, Closures) |
| 4371 | 21 CFR 211.188(b)(9) | Description of containers and closures |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |