FDA Inspection 1273782 — HeartStitch, Inc.
The FDA completed an inspection of HeartStitch, Inc. on Jun 25, 2025 in Fountain Valley, CA. 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 25, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fountain Valley, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3696 | 21 CFR 820.100(b) | Documentation |