Boston Scientific Corporation (NYSE: BSX), Minnetonka, MN – FDA Inspections
Inspection records and compliance data for Boston Scientific Corporation in Minnetonka, Minnesota. 8 FDA inspections on record (1 OAI), last inspected December 11, 2017. Publicly traded as NYSE: BSX.
This profile covers Boston Scientific Corporation based in Minnetonka, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 1
- VAI
- 3
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected January 28, 2009. Last inspected December 11, 2017.
Most cited issue areas
- Lack of or inadequate process validation2 inspections
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 11, 2017 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1036678 |
| June 27, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1018598 |
| January 29, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 958603 |
| February 24, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 868462 |
| April 25, 2013 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 828801 |
| February 15, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 818398 |
| July 13, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 733567 |
| January 28, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 564982 |
No Form 483s, Warning Letters or EIRs on record.
Companies with similar regulatory profiles, compliance history, and operations.
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
1000116179
Address
10700 Bren Rd W, Minnetonka, Minnesota 55343, United States
Country
United States
ID: e946cdb3-4277-49e2-91b8-a3e3437a0104