FDA Inspection
Stryker Puerto Rico, LLCStryker Puerto Rico, LLC – FDA Inspection, Feb 20, 2026
Record Details
This FDA Inspection record concerns Stryker Puerto Rico, LLC, with an inspection on February 20, 2026, issued by the San Juan District Office, covering medical devices & rad health.
- Company
- Stryker Puerto Rico, LLC
- Inspection Date
- February 20, 2026
- Product Type
- Medical Devices & Rad Health
- Office
- San Juan District Office
- Person
View Company Profile
ID · 4b65237e-5ae8-414c-8964-52ba80f282ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1303670
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
2- ISO 13485:2016 Clause 7.5.6Planned results not consistently met during validation of processes
- ISO 13485:2016 Clause 8.2.5Suitable methods for monitoring and measuring QMS processes not applied
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Other FDA inspections of Stryker Puerto Rico, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 25, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 11, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 27, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 14, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 20, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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