FDA Inspection 1111775 — Circulatory Technology Inc.
The FDA completed an inspection of Circulatory Technology Inc. on Dec 4, 2019 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 4, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Oyster Bay, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 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 |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |