FDA Inspection 810555 — Vortech Pharmaceuticals Ltd
The FDA completed an inspection of Vortech Pharmaceuticals Ltd on December 14, 2012 in Dearborn, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 14, 2012
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Dearborn, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |