# FDA 483 - Vista Lifesciences, Inc. - November 04, 2025

Source: https://www.keypedia.com/records/483/vista-lifesciences-inc/c199b7b5-821f-4049-8bb3-5ac272f27708

> FDA 483 for Vista Lifesciences, Inc. on November 04, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vista Lifesciences, Inc.
- Inspection Date: 2025-11-04
- Product Type: device
- Office Name: FDA District Office — Denver, Colorado
- Summary: An FDA inspection of Vista Lifesciences, Inc., a medical device manufacturer in Englewood, CO, revealed significant deficiencies in their quality system. The firm's corrective and preventive action (CAPA) procedures were not adequately established. This included failures to document root cause investigations and to ensure effectiveness checks verified that corrective actions addressed the original root causes of non-conformities.

## Related Documents

- [483 - 2019-02-11](https://www.keypedia.com/records/483/vista-lifesciences-inc/4d1cde3d-7aff-4f75-bfe6-a8b3b4dd6884)
- [483 - 2025-11-04](https://www.keypedia.com/records/483/vista-lifesciences-inc/d8db1c5d-1948-42ae-ae78-b0685c31c95b)

## Related Officers

- [investigator](https://www.keypedia.com/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)
- [Patrick D. Galdun](https://www.keypedia.com/people/patrick-d-galdun/ff3e8c02-99a6-406e-80f3-ce7901b58015)

Company: https://www.keypedia.com/companies/vista-lifesciences-inc/c3853c8e-2979-4b4a-939d-bdc2a3942176

Office: https://www.keypedia.com/offices/fda-district-office-denver-colorado/1670d160-cbfd-48fd-b9c1-fbba4631fcb0