FDA Inspection 1270932 — SV Labs Prescott Corporation
The FDA completed an inspection of SV Labs Prescott Corporation on Jun 13, 2025 in Prescott, WI. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 14 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 13, 2025
- Fiscal Year
- 2025
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Prescott, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |