Warning letter
Deroyal Cientifica De Latinoamerica S.R.L.: warning letter of Aug 12, 2013
FDA warning letter 406127 · Center for Devices and Radiological Health
Key facts
| Reference number | 406127 |
|---|---|
| Company | Deroyal Cientifica De Latinoamerica S.R.L. |
| Subject | Medical Device Reporting Regulation/Misbranded |
| Issue date | Aug 12, 2013 |
| Posted date | Aug 12, 2013 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.52, 803.17(a), 803.20(c)(1), 803.18(e), 820, 820.40, 803.50(a) |
| Inspection city | Heredia |
| Inspection start date | Feb 25, 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: