FDA Inspection 702921 — Tenda Horse Products LLC
The FDA completed an inspection of Tenda Horse Products LLC on Dec 21, 2010 in Sandusky, OH. 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). 8 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 21, 2010
- Fiscal Year
- 2011
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Sandusky, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1546 | 21 CFR 211.125(d) | Destruction of excess labels with lot numbers |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |