FDA Inspection 811379 — Tenda Horse Products LLC
The FDA completed an inspection of Tenda Horse Products LLC on Dec 20, 2012 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). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 20, 2012
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Sandusky, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1724 | 21 CFR 211.134(b) | Representative samples after completion |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |