FDA Inspection 856394 — Hawthorne Products, Inc
The FDA completed an inspection of Hawthorne Products, Inc on November 19, 2013 in Dunkirk, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 19, 2013
- Fiscal Year
- 2014
- 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 |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 2203 | 21 CFR 211.186(b)(7) | Theoretical Yield and Percentages |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4386 | 21 CFR 211.198(b) | Written complaint record to be maintained at facility |