FDA Inspection
Abiomed, Inc.Abiomed, Inc. – FDA Inspection, Aug 5, 2025
Record Details
This FDA Inspection record concerns Abiomed, Inc., with an inspection on August 5, 2025, issued by the New England District Office, covering medical devices & rad health.
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ID · 398d847d-0cad-45aa-a294-fe023d6384fe
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1234317
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 806.10(a)(1)Report of risk to health
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Abiomed, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| October 9, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Abiomed, Inc.
- FDA Inspection 1202491 - 2023-04-13
- FDA Inspection 1131459 - 2020-10-06
- FDA Inspection 1021587 - 2017-07-27
- FDA Inspection 964416 - 2016-03-25
- FDA Inspection 899479 - 2014-10-09
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