# FDA WARNING_LETTER - Vital Juice Company, Inc. - November 21, 2014

Source: https://www.keypedia.com/records/warning_letter/vital-juice-company-inc/171da5df-8b65-4c3b-93c1-9188df767dec

> FDA WARNING_LETTER for Vital Juice Company, Inc. on November 21, 2014. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Vital Juice Company, Inc.
- Inspection Date: 2014-11-21
- Product Type: Food
- Office Name: Seattle District Office
- Summary: The FDA inspected a juice processing facility in Seattle, Washington, from November 19-21, 2014, revealing serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120). This renders the firm's 100% juice blends and 60-90% juice products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include:
1.  **Inadequate 5-log reduction validation:** The HACCP plan's critical limits for 100% and 60-90% juice products were not validated to achieve a 5-log reduction of pertinent microorganisms, as required by 21 CFR Part 120.24. A validation study was inadequate, failing to show a 5-log reduction for several products and not identifying pertinent microorganisms. A second study on "vital greens" used parameters not routinely met by the product's pH, and no validation was conducted for the current HPP treatment.
2.  **Missing critical control points/limits:** The HACCP plan for "Fresh Squeezed and Cold-Pressed Fruit and Vegetable Juices" did not identify blending/filling as a critical control point or list pH 4.6 at this step to control *Clostridium botulinum*, violating 21 CFR

## Related Officers

- [Miriam R. Burbach](https://www.keypedia.com/people/miriam-r-burbach/68959b72-6f58-4d4b-9329-5109ffe8a649)

Company: https://www.keypedia.com/companies/vital-juice-company-inc/f43fe980-c713-454e-aca9-301f1dc48d57

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913