769028
Hawthorne Products, Inc — FEI 1824900
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 25, 2012
- Fiscal Year
- 2012
- 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 |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2019 | 21 CFR 211.188(b)(7) | Documentation of Actual Yield and Theoretical Yield |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4317 | 21 CFR 211.84(d)(3) | Certificates of Testing (Containers, Closures) |
| 4344 | 21 CFR 211.160(b)(1) | Sampling and testing procedures described |
| 4347 | 21 CFR 211.160(b)(2) | In process materials - conformance to written specs |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |