FDA Inspection 847671 — Heartsine Technologies Inc
The FDA completed an inspection of Heartsine Technologies Inc on August 22, 2013 in Newtown, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 22, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Newtown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4249 | 21 CFR 821.25(c) | Not established, maintained |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |