FDA Inspection 916489 — Bonafix Surgical And Dental Implants, LLC
The FDA completed an inspection of Bonafix Surgical And Dental Implants, LLC on Feb 27, 2015 in Delray Beach, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 27, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Delray Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 14719 | 21 CFR 820.30(h) | Incorrect translation to production specifications |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |