1012840
Nytone Medical Products, Inc. — FEI 1718047
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 5, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bluffdale, UT (United States)
Citations
| ID | CFR | Description |
|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |