# Stryker Puerto Rico, LLC – FDA 483, Feb 20, 2026

Source: https://www.keypedia.com/records/483/stryker-puerto-rico-llc/42ee4805-3f22-46d5-9e5b-afe49495aa9c

> FDA 483 for Stryker Puerto Rico, LLC on February 20, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stryker Puerto Rico, LLC
- Inspection Date: 2026-02-20
- Product Type: device
- Office Name: San Juan District Office
- Summary: Stryker Puerto Rico, LLC, a medical device manufacturer in Arroyo, PR, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately validate a critical test method used to detect manufacturing defects in its StrykeFlow 2 product family, a product that previously experienced a recall. Additionally, the methods for monitoring quality management system processes were found to be inadequate, specifically regarding data collection, action triggers for deviations, and data verification.

## Related Officers

- [Monica C. Burgos Garcia](https://www.keypedia.com/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)

Company: https://www.keypedia.com/companies/stryker-puerto-rico-llc/15ef9e21-ef4c-473e-af65-f2cd3b7cc07f

Office: https://www.keypedia.com/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8