FDA Inspection 1067277 — Circulatory Technology Inc.
The FDA completed an inspection of Circulatory Technology Inc. on September 26, 2018 in Oyster Bay, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 26, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Oyster Bay, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |