# FDA 483 - GPI USA, Inc. - August 25, 2023

Source: https://www.keypedia.com/records/483/gpi-usa-inc/5739a5c5-66e3-4f3e-b5c9-5a75626772dd

> FDA 483 for GPI USA, Inc. on August 25, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GPI USA, Inc.
- Inspection Date: 2023-08-25
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: GPI USA, Inc., a software manufacturer in Houston, TX, was cited with two observations during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, specifically lacking a risk-based approach for impact assessment in their CAPA process. Additionally, procedures for design verification were not adequately established, as an unimplemented work instruction was used for verification testing of their e-Delphyn Donor Software, leading to test failures.

## Related Officers

- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)
- [Lesley Mae P. Lutao](https://www.keypedia.com/people/lesley-mae-p-lutao/bfdcc755-28e5-4caf-91f9-b9579df4731e)

Company: https://www.keypedia.com/companies/gpi-usa-inc/bfa89195-4ffe-4a1b-82d5-cfc5bb257254

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab