849799
International Biophysics Corp. — FEI 1000117854
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 30, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |