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1303670

Stryker Puerto Rico, LLC — FEI 2648666

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 20, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Arroyo, PR (United States)

Facility

Other inspections at this facility

  • 1204476 (NAI Tue Apr 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1123176 (NAI Tue Feb 11 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1003401 (NAI Mon Feb 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 909000 (NAI Fri Nov 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 588347 (NAI Wed May 20 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
23168ISO 13485:2016 Clause 7.5.6Planned results not consistently met during validation of processes
23227ISO 13485:2016 Clause 8.2.5Suitable methods for monitoring and measuring QMS processes not applied