FDA Inspection 976745 — Circulatory Technology Inc.
The FDA completed an inspection of Circulatory Technology Inc. on Jul 8, 2016 in Oyster Bay, NY. 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). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 8, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Oyster Bay, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 648 | 21 CFR 803.18(e) | MDR not evaluated per 820.198 |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |