Warning letter
Abiomed Inc.: warning letter of Sep 19, 2023
FDA warning letter 663150 · Division of Medical Device and Radiological Health Operations East
Key facts
| Reference number | 663150 |
|---|---|
| Company | Abiomed Inc. |
| Subject | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded |
| Issue date | Sep 19, 2023 |
| Posted date | Oct 10, 2023 |
| Issuing office | Division of Medical Device and Radiological Health Operations East |
| Product type | Devices |
| CFR sections cited | 807.81(b), 803, 803.3, 803.50, 806, 803.50(a)(1), 803.50(a)(2), 820, 806.10(b) |
| Inspection city | Danvers |
| Inspection ZIP | 01923 |
| Inspection start date | Mar 1, 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: