FDA Inspection 652147 — Circulatory Technology Inc.
The FDA completed an inspection of Circulatory Technology Inc. on Mar 15, 2010 in Oyster Bay, NY. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 15, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Oyster Bay, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 4189 | 21 CFR 820.198(a) | General |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |