FDA Inspection 652945 — Heartsine Technologies Inc
The FDA completed an inspection of Heartsine Technologies Inc on Mar 16, 2010 in Newtown, PA. 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
- Mar 16, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Newtown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |