FDA Inspection 1093858 — Thorn BioScience LLC
The FDA completed an inspection of Thorn BioScience LLC on June 7, 2019 in Louisville, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 7, 2019
- Fiscal Year
- 2019
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Louisville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1219 | 21 CFR 211.67(b)(2) | Cleaning SOPs/schedules |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2405 | 21 CFR 211.194(a)(7) | Identification of Person Performing the Testing |
| 4354 | 21 CFR 211.165(d) | Acceptance/Rejection Levels |