Company
United StatesStryker Puerto Rico, LLC, Arroyo, PR – FDA Inspections
Inspection records and compliance data for Stryker Puerto Rico, LLC in Arroyo, Puerto Rico. 6 FDA inspections on record, 1 Form 483, last inspected February 20, 2026.
Company Profile
This profile covers Stryker Puerto Rico, LLC based in Arroyo, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 1
- NAI
- 5
- Form 483s
- 1
- Warning letters
- 0
First inspected May 20, 2009. Last inspected February 20, 2026.
Most cited issue areas
- Planned results not consistently met during validation of processes1 inspection
- Suitable methods for monitoring and measuring QMS processes not applied1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 20, 2026 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1303670 |
| April 25, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1204476 |
| February 11, 2020 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1123176 |
| February 27, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1003401 |
| November 14, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 909000 |
| May 20, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 588347 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Stryker Puerto Rico, LLC
FEI Number
2648666
Address
Highway 3, Km. 131.2, Las Guasimas Industrial Park, Arroyo, Puerto Rico 00714, United States
Country
United States
ID: 15ef9e21-ef4c-473e-af65-f2cd3b7cc07f