Warning letter
Agena Bioscience, Inc.: warning letter of Mar 21, 2024
FDA warning letter 665159 · Center for Devices and Radiological Health
Key facts
| Reference number | 665159 |
|---|---|
| Company | Agena Bioscience, Inc. |
| Subject | Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k) |
| Issue date | Mar 21, 2024 |
| Posted date | Apr 2, 2024 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 806, 806.10, 864.7280, 807.81(a)(1), 807.81(a)(3), 809.10(c)(2)(i), 807.81(b), 809.10(c) |
| Inspection city | San Diego |
| Inspection ZIP | 92121 |
| Inspection start date | Jun 7, 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: