Warning letter
21st Century Scientific Inc: warning letter of May 13, 2019
FDA warning letter 566834 · Center for Devices and Radiological Health
Key facts
| Reference number | 566834 |
|---|---|
| Company | 21st Century Scientific Inc |
| Subject | Medical Device Reporting/Misbranded |
| Issue date | May 13, 2019 |
| Posted date | Sep 17, 2019 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 807.81(a)(3), 803.17, 803.17(a)(1), 803.17(a)(2), 803.17(a)(3), 803.17(b), 803.50(a)(1), 803.50(a), 803, 803.3 |
| Inspection city | Coeur d Alene |
| Inspection ZIP | 83815 |
| Inspection start date | Sep 10, 2018 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 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: