588881
Nytone Medical Products, Inc. — FEI 1718047
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 5, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bluffdale, UT (United States)
Citations
| ID | CFR | Description |
|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3284 | 21 CFR 820.90(a) | Nonconforming product evaluation/investigation |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 4189 | 21 CFR 820.198(a) | General |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |