FDA Inspection
Abiomed, Inc.Abiomed, Inc. – FDA Inspection, Apr 13, 2023
Record Details
This FDA Inspection record concerns Abiomed, Inc., with an inspection on April 13, 2023, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Justine M. Corson (FDA Associated Person)
- Kalkidan A. Molla
View Company Profile
ID · fcd3c682-3568-4f99-b9fd-b1b85a1ab600
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1202491
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.100(a)Lack of or inadequate procedures
Showing 10 of 12 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Abiomed, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| August 5, 2025 | OAI | New England District Office | Compliance: Medical 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 1234317 - 2025-08-05
- FDA Inspection 1131459 - 2020-10-06
- FDA Inspection 1021587 - 2017-07-27
- FDA Inspection 964416 - 2016-03-25
- FDA Inspection 899479 - 2014-10-09
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.