FDA Inspection 1234317 — Abiomed, Inc.
The FDA completed an inspection of Abiomed, Inc. on Aug 5, 2025 in Danvers, MA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 5, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Danvers, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |