FDA Inspection 1303670 — Stryker Puerto Rico, LLC
The FDA completed an inspection of Stryker Puerto Rico, LLC on February 20, 2026 in Arroyo, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
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)
Citations
| ID | CFR | Description |
|---|---|---|
| 23168 | ISO 13485:2016 Clause 7.5.6 | Planned results not consistently met during validation of processes |
| 23227 | ISO 13485:2016 Clause 8.2.5 | Suitable methods for monitoring and measuring QMS processes not applied |