1063445
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 20, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Fresno, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |