Company
United StatesAbiomed, Inc., Danvers, MA – FDA Inspections
Inspection records and compliance data for Abiomed, Inc. in Danvers, Massachusetts. 9 FDA inspections on record (2 OAI), 2 Form 483s, last inspected August 05, 2025.
Company Profile
This profile covers Abiomed, Inc. based in Danvers, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 2
- VAI
- 2
- NAI
- 5
- Form 483s
- 2
- Warning letters
- 0
First inspected March 17, 2010. Last inspected August 5, 2025.
Most cited issue areas
- Report of Death or Serious Injury3 inspections
- Lack of or inadequate procedures2 inspections
- Report of risk to health2 inspections
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 5, 2025 | OAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1234317 |
| April 13, 2023 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1202491 |
| October 6, 2020 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1131459 |
| July 27, 2017 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1021587 |
| March 25, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 964416 |
| October 9, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 899479 |
| July 15, 2014 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 887169 |
| June 18, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 786999 |
| March 17, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 652658 |
FDA documents
Form 483s (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Abiomed, Inc.
FEI Number
1220648
Address
24 Cherry Hill Dr, Danvers, Massachusetts 01923, United States
Country
United States
ID: bf75e76c-c813-4c91-81e2-a86e5707a511