FDA inspection
Abiomed, Inc.: FDA inspection ending Apr 13, 2023
FDA inspection 1202491 · Official Action Indicated (OAI) · Danvers, MA
Key facts
| Inspection ID | 1202491 |
|---|---|
| Firm | Abiomed, Inc. |
| FEI number | 1220648 |
| Address | 24 Cherry Hill Dr |
| City | Danvers |
| State | MA |
| ZIP | 01923 |
| Country | United States |
| Fiscal year | 2023 |
| Inspection end date | Apr 13, 2023 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 663150 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data