1166833
Applied Neuroscience, Inc. — FEI 3004577596
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 11, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- St Petersburg, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 21426 | 21 CFR 820.198(e) | Records of complaint investigation - UDI |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |