FDA Inspection 542600 — Via Biomedical
The FDA completed an inspection of Via Biomedical on Oct 24, 2008 in Maple Grove, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 13 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 24, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Maple Grove, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 3250 | 21 CFR 820.72(b)(2) | Calibration documentation |
| 3284 | 21 CFR 820.90(a) | Nonconforming product evaluation/investigation |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3687 | 21 CFR 820.100(a)(1) | Analysis of data sources |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4189 | 21 CFR 820.198(a) | General |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |