FDA Inspection 958602 — Donald L. Scott LLC
The FDA completed an inspection of Donald L. Scott LLC on February 4, 2016 in Monroeville, IN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 4, 2016
- Fiscal Year
- 2016
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Monroeville, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 13541 | FDCA 501(a)(5) | Use of veterinary prescription drug(s) without a prescription |
| 1362 | 21 CFR 530.11(a) | Species or class |
| 1366 | 21 CFR 530.11(a) | Dosage level |
| 1373 | 21 CFR 530.11(a) | Route of administration |
| 4094 | 21 CFR 530.11(b) | Use in animal feed |
| 4182 | FDCA 501(a)(5) | ELDU without veterinary client-patient relationship |
| 4185 | FDCA 402(a)(4) | Record keeping |