# FDA 483 - VIANT PUERTO RICO, INC - December 19, 2025

Source: https://www.keypedia.com/records/483/viant-puerto-rico-inc/ff17c58e-b665-460d-8993-bbc2150b6bf4

> FDA 483 for VIANT PUERTO RICO, INC on December 19, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: VIANT PUERTO RICO, INC
- Inspection Date: 2025-12-19
- Product Type: device
- Office Name: San Juan District Office
- Summary: VIANT PUERTO RICO, INC, a combination product manufacturer in Vega Baja, PR, was cited for significant quality system deficiencies during an FDA inspection. Observations included failures in data integrity, inadequate equipment design and validation, non-adherence to production and process control procedures, and issues with supplier qualification. These findings indicate a need for comprehensive improvements across several critical operational areas.

## Related Documents

- [483 - 2025-05-02](https://www.keypedia.com/records/483/viant-puerto-rico-inc/eeca776c-b519-402e-8157-1f4cfde5d327)

## Related Officers

- [Jose F. Velez](https://www.keypedia.com/people/jose-f-velez/0d1951e8-3aa5-48ff-bc54-1fae8a7a57c9)
- [Medical Device Specialist](https://www.keypedia.com/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.keypedia.com/companies/viant-puerto-rico-inc/09c9fa1a-d7fb-4b1c-bf4e-54c448fd8255

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