Warning letter
Terragene S.A.: warning letter of Nov 1, 2023
FDA warning letter 667432 · Center for Devices and Radiological Health
Key facts
| Reference number | 667432 |
|---|---|
| Company | Terragene S.A. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Nov 1, 2023 |
| Posted date | Dec 26, 2023 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 807.81(b), 820, 803.17 |
| Inspection city | Alvear |
| Inspection start date | Jun 6, 2023 |
| Letter on fda.gov | fda.gov |
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: