FDA Inspection 1177544 — CardioFocus, Inc.
The FDA completed an inspection of CardioFocus, Inc. on August 11, 2022 in Marlborough, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 11, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Marlborough, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |