FDA Inspection
Abiomed, Inc.Abiomed, Inc. – FDA Inspection, Mar 17, 2010
Record Details
This FDA Inspection record concerns Abiomed, Inc., with an inspection on March 17, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Abiomed, Inc.
- Inspection Date
- March 17, 2010
- Product Type
- Devices
View Company Profile
ID · 4c131e12-9285-4fe2-8883-33b8a9b7ac00
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 652658
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.198(a)(1)Uniform and timely processing
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Other FDA inspections of Abiomed, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| August 5, 2025 | OAI | New England District Office | Compliance: Medical Devices |
| April 13, 2023 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 6, 2020 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| July 27, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| March 25, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Abiomed, Inc.
- FDA Inspection 1234317 - 2025-08-05
- FDA Inspection 1202491 - 2023-04-13
- FDA Inspection 1131459 - 2020-10-06
- FDA Inspection 1021587 - 2017-07-27
- FDA Inspection 964416 - 2016-03-25
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