Company
United StatesPublic company, NYSE: BSXBoston Scientific Corporation (NYSE: BSX), Marlborough, MA – FDA Inspections
Inspection records and compliance data for Boston Scientific Corporation in Marlborough, Massachusetts. 14 FDA inspections on record, 2 Form 483s, last inspected November 26, 2024. Publicly traded as NYSE: BSX.
Company Profile
This profile covers Boston Scientific Corporation based in Marlborough, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 14
- OAI
- 0
- VAI
- 2
- NAI
- 5
- Unclassified
- 7
- Form 483s
- 2
- Warning letters
- 0
First inspected November 18, 2009. Last inspected November 26, 2024.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Individual Report of Malfunction1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (14)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 26, 2024 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1246067 |
| January 13, 2023 | Not classified | Medical Devices & Rad Health | 1196120 |
| June 7, 2019 | Not classified | Medical Devices & Rad Health | 1130716 |
| May 29, 2019 | Not classified | Medical Devices & Rad Health | 1117032 |
| October 31, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1072267 |
| September 20, 2018 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1068733 |
| December 6, 2017 | Not classified | Medical Devices & Rad Health | 1053467 |
| September 20, 2017 | Not classified | Medical Devices & Rad Health | 1051801 |
| June 9, 2017 | Not classified | Medical Devices & Rad Health | 1034835 |
| May 19, 2017 | Not classified | Medical Devices & Rad Health | 1030731 |
| July 12, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 977724 |
| October 24, 2013 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 853358 |
| July 10, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 790237 |
| November 18, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 630487 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Boston Scientific Corporation
Stock ticker
BSX
Exchange
NYSE
Share price
$44.61
Market cap
$64.7B
Price as of
November 6, 2026
FEI Number
3005099803
Address
100 Boston Scientific Way, Marlborough, Massachusetts 01752, United States
Country
United States
ID: 7b03f40b-d516-4bcb-9702-929c6f485000