FDA Inspection 912236 — Finish Line Horse Products, Inc.
The FDA completed an inspection of Finish Line Horse Products, Inc. on February 17, 2015 in Bensenville, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 17, 2015
- Fiscal Year
- 2015
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Bensenville, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1791 | 21 CFR 211.80(c) | Storage off Floor, Spaced Suitably |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4328 | 21 CFR 211.122(a) | Written procedures not followed |