Warning letter
Gooten Innolife Corp: warning letter of Jul 16, 2012
FDA warning letter 307238 · Center for Devices and Radiological Health
Key facts
| Reference number | 307238 |
|---|---|
| Company | Gooten Innolife Corp |
| Subject | Adulterated Device/Misbranded |
| Issue date | Jul 16, 2012 |
| Posted date | Jul 16, 2012 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 807.20(a), 803, 803.3, 803.17, 820, 820.40, 803.50(b), 807.81(b) |
| Inspection city | Taichung |
| Inspection start date | Mar 5, 2012 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- 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: