# FDA 483 - Immune & Genetics Protocols, LLC - November 06, 2023

Source: https://www.globalkeysolutions.net/records/483/immune-genetics-protocols-llc/c4aa007f-5283-4eb2-8e6b-cdd46e268394

> FDA 483 for Immune & Genetics Protocols, LLC on November 06, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Immune & Genetics Protocols, LLC
- Inspection Date: 2023-11-06
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Immune & Genetics Protocols, LLC in Ocala, FL, an Own Label Distributor, identified two significant observations. The firm failed to establish product specifications for finished dietary supplements, specifically for Immune Bio Green Cell. Additionally, the company lacked written procedures for holding and distributing dietary supplements.

## Related Documents

- [WARNING_LETTER - 2021-03-30](https://www.globalkeysolutions.net/records/warning_letter/immune-genetics-protocols-llc/8a306993-a147-4f30-9f33-393c56aebc44)

## Related Officers

- [Juan C. Gonzalez Rivera](https://www.globalkeysolutions.net/people/juan-c-gonzalez-rivera/89cede20-6837-417d-b4d8-223eda5b641d)

Company: https://www.globalkeysolutions.net/companies/immune-genetics-protocols-llc/610c62ae-8dcf-45f5-a4f5-90d0f896d963

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6