# FDA 483 - Global Vitality Inc. - July 28, 2021

Source: https://www.keypedia.com/records/483/global-vitality-inc/ea3c9d31-2f45-4dc9-9d8b-37df6f665b0a

> FDA 483 for Global Vitality Inc. on July 28, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Global Vitality Inc.
- Inspection Date: 2021-07-28
- Product Type: other
- Office Name: Denver District Office
- Summary: An FDA inspection of Global Vitality, Inc. dba Enzyme Process International revealed significant and repeat deficiencies in quality control and manufacturing processes. The firm failed to ensure scientifically valid test methods, maintain complete and accurate batch production records, and adhere to basic hygienic practices, leading to the release of products that did not meet established specifications. These systemic issues, many of which were repeat observations from prior inspections, indicate a critical lack of compliance with good manufacturing practices.

## Related Documents

- [483 - 2019-04-24](https://www.keypedia.com/records/483/global-vitality-inc/386cf4d3-1b32-463f-b2b9-b956ca2e078e)

## Related Officers

- [Mary C Pasic](https://www.keypedia.com/people/mary-c-pasic/6051d864-e1c5-41e3-8219-effb4b687018)
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- [Samantha E. Rafferty](https://www.keypedia.com/people/samantha-e-rafferty/a12761c8-25b0-4fa2-91e7-8071414bee7e)
- [Brenda Chavez](https://www.keypedia.com/people/brenda-chavez/a83afdd6-24c5-47d9-a091-8bc5f771e3cf)

Company: https://www.keypedia.com/companies/global-vitality-inc/54edd927-fab0-4bd7-b4ba-010315a54817

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face