FDA Inspection 601913 — Heartsine Technologies Inc
The FDA completed an inspection of Heartsine Technologies Inc on August 4, 2009 in Newtown, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 4, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Newtown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4189 | 21 CFR 820.198(a) | General |
| 4248 | 21 CFR 821.25(b) | Records not current |
| 4250 | 21 CFR 821.25(c)(1) | Missing data |
| 4252 | 21 CFR 821.25(c)(3) | Quality assurance procedures: 6-month & annual audits |