FDA Inspection 662248 — Applied Neuro Technology
The FDA completed an inspection of Applied Neuro Technology on May 25, 2010 in Altadena, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 25, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Altadena, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 4189 | 21 CFR 820.198(a) | General |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |