Warning letter
HSMG, Inc. D/b/a Smartinfuser USA [ARCHIVED]: warning letter of Jul 29, 2010
FDA warning letter 103567 · Dallas District Office
Key facts
| Reference number | 103567 |
|---|---|
| Company | HSMG, Inc. D/b/a Smartinfuser USA [ARCHIVED] |
| Subject | Medical Device Reporting Regulation/Misbranded |
| Issue date | Jul 29, 2010 |
| Posted date | Jul 29, 2010 |
| Issuing office | Dallas District Office |
| Product type | Devices |
| CFR sections cited | 803.17, 806, 806.10(a)(1), 820, 803, 803.40(a) |
| Inspection city | Houston |
| Inspection ZIP | 77024 |
| Inspection start date | Nov 17, 2009 |
| 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: