FDA Inspection 669163 — Vortech Pharmaceuticals Ltd
The FDA completed an inspection of Vortech Pharmaceuticals Ltd on June 28, 2010 in Dearborn, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 28, 2010
- Fiscal Year
- 2010
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Dearborn, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |