Warning letter
OriGen Biomedical, Inc.: warning letter of Dec 20, 2018
FDA warning letter 569074 · Division of Medical Device and Radiological Health Operations West
Key facts
| Reference number | 569074 |
|---|---|
| Company | OriGen Biomedical, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Dec 20, 2018 |
| Posted date | Jun 4, 2019 |
| Issuing office | Division of Medical Device and Radiological Health Operations West |
| Product type | Devices |
| CFR sections cited | 820.40, 803, 803.17, 806, 806.10, 803.17(a)(1), 803.17(a)(3), 803.17(b), 803.20(c)(1), 803.50(a)(1), 803.50(a)(2), 820 and 1 more |
| Inspection city | Austin |
| Inspection ZIP | 78744 |
| Inspection start date | Jun 11, 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: