FDA Inspection 1084039 — Finish Line Horse Products, Inc.
The FDA completed an inspection of Finish Line Horse Products, Inc. on March 27, 2019 in Bensenville, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 27, 2019
- Fiscal Year
- 2019
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Bensenville, IL (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 |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |