FDA Inspection 1022297 — Vortech Pharmaceuticals Ltd
The FDA completed an inspection of Vortech Pharmaceuticals Ltd on August 16, 2017 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
- August 16, 2017
- Fiscal Year
- 2017
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Dearborn, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |