FDA Inspection 573290 — Faxitron Bioptics, LLC
The FDA completed an inspection of Faxitron Bioptics, LLC on April 2, 2009 in Tucson, AZ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 2, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Tucson, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3299 | 21 CFR 820.100(a)(1) | Procedure for analysis of data sources |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3380 | 21 CFR 820.198(e)(6) | Results of investigation |
| 3381 | 21 CFR 820.198(e)(7) | Corrective action taken |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3428 | 21 CFR 820.50(a)(3) | Acceptable supplier records |
| 3664 | 21 CFR 820.20(b)(2) | Training |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3696 | 21 CFR 820.100(b) | Documentation |