Company
United StatesStryker Spine, Allendale, NJ – FDA Inspections
Inspection records and compliance data for Stryker Spine in Allendale, New Jersey. 8 FDA inspections on record, last inspected September 27, 2024.
Company Profile
This profile covers Stryker Spine based in Allendale, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 1
- NAI
- 7
- Form 483s
- 0
- Warning letters
- 0
First inspected March 17, 2010. Last inspected September 27, 2024.
Most cited issue areas
- Device identification and control number1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 27, 2024 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1251341 |
| September 13, 2021 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1155286 |
| August 1, 2019 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1099091 |
| March 11, 2016 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 965950 |
| June 18, 2014 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 883814 |
| January 12, 2012 | NAI | Biologics, Medical Devices & Rad Health · Compliance: Devices | 763943 |
| August 20, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 679590 |
| March 17, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 656354 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Stryker Spine
FEI Number
3004024955
Address
59 State Rt 17 S, Allendale, New Jersey 07401, United States
Country
United States
ID: 9eecc83b-d4a3-4769-830f-9d237adc74e5