Warning letter
Heartsine Technologies Inc: warning letter of Feb 3, 2014
FDA warning letter 415706 · Philadelphia District Office
Key facts
| Reference number | 415706 |
|---|---|
| Company | Heartsine Technologies Inc |
| Subject | Medical Device Reporting (MDR) Regulation |
| Issue date | Feb 3, 2014 |
| Posted date | Feb 11, 2014 |
| Issuing office | Philadelphia District Office |
| Product type | Devices |
| CFR sections cited | 803.17, 821, 803.50(a)(2), 821.25(c)(3), 803.50(a), 803.50(b), 821.25(b) |
| Inspection city | Newtown |
| Inspection ZIP | 18940 |
| Inspection start date | Aug 13, 2013 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: