FDA Inspection 662559 — Thorn BioScience LLC
The FDA completed an inspection of Thorn BioScience LLC on May 6, 2010 in Louisville, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 6, 2010
- Fiscal Year
- 2010
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Louisville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 2035 | 21 CFR 211.194(e) | Stability testing records not included |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |