FDA Inspection 1025766 — Minnesota Valley Testing Laboratories Inc.
The FDA completed an inspection of Minnesota Valley Testing Laboratories Inc. on April 25, 2017 in New Ulm, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 25, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- New Ulm, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |