# FDA 483 - Global Vitality Inc. - April 24, 2019

Source: https://www.globalkeysolutions.net/records/483/global-vitality-inc/386cf4d3-1b32-463f-b2b9-b956ca2e078e

> FDA 483 for Global Vitality Inc. on April 24, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Global Vitality Inc.
- Inspection Date: 2019-04-24
- Product Type: other
- Office Name: Denver District Office
- Summary: Global Vitality, Inc. dba Enzyme Process International, a dietary supplement manufacturer in Chandler, AZ, received an FDA Form 483 citing numerous deficiencies. The inspection revealed significant issues with quality control operations, including failure to reject non-conforming raw materials and incorrect product labeling, as well as inadequate record-keeping for batch production and laboratory operations. The firm also failed to establish appropriate specifications for raw materials, in-process materials, and finished dietary supplements, with several repeat observations from a previous inspection.

## Related Documents

- [483 - 2021-07-28](https://www.globalkeysolutions.net/records/483/global-vitality-inc/ea3c9d31-2f45-4dc9-9d8b-37df6f665b0a)

## Related Officers

- [Siobhan A Gallagher](https://www.globalkeysolutions.net/people/siobhan-a-gallagher/5a741224-46c8-4224-9b0f-72c164e600b9)
- [Pharmaceutical investigator](https://www.globalkeysolutions.net/people/bryan-a-galvez/d1e52abc-5b56-4ffb-af22-90e6733fb73a)

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

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