Company
United StatesStryker Medical Division of Stryker Corporation, Portage, MI – FDA Inspections
Inspection records and compliance data for Stryker Medical Division of Stryker Corporation in Portage, Michigan. 6 FDA inspections on record (1 OAI), 2 Form 483s, last inspected November 15, 2024.
Company Profile
This profile covers Stryker Medical Division of Stryker Corporation based in Portage, Michigan, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 3
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected May 15, 2009. Last inspected November 15, 2024.
Most cited issue areas
- Design verification - Lack of or inadequate procedures2 inspections
- Individual Report of Malfunction2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 15, 2024 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1255124 |
| March 1, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1003139 |
| October 13, 2016 | Not classified | Medical Devices & Rad Health | 996318 |
| June 26, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 791490 |
| September 24, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 682480 |
| May 15, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 584103 |
FDA documents
Form 483s (1)
EIRs (1)
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Company Information
Name
Stryker Medical Division of Stryker Corporation
FEI Number
1831750
Address
3800 E Centre Ave, Portage, Michigan 49002, United States
Country
United States
ID: 8540f6c7-6bb7-4c61-a1e6-cefe0fd53937