FDA Inspection 936945 — Circulatory Technology Inc.
The FDA completed an inspection of Circulatory Technology Inc. on Jul 31, 2015 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 31, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Oyster Bay, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 3696 | 21 CFR 820.100(b) | Documentation |