FDA Inspection 652658 — Abiomed, Inc.
The FDA completed an inspection of Abiomed, Inc. on Mar 17, 2010 in Danvers, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 17, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Danvers, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 4193 | 21 CFR 806.10(b) | Time to report - 10 days |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |