# FDA WARNING_LETTER - Juices Enterprises Inc. - November 21, 2007

Source: https://www.keypedia.com/records/warning_letter/juices-enterprises-inc/5ebabac6-3179-4360-b3aa-090500eaaf18

> FDA WARNING_LETTER for Juices Enterprises Inc. on November 21, 2007. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Juices Enterprises Inc.
- Inspection Date: 2007-11-21
- Product Type: Food
- Office Name: New York District Office
- Summary: On November 13-21, 2007, the FDA inspected Juices Enterprises Inc., identifying serious violations of juice HACCP (21 CFR Part 120) and GMP (21 CFR Part 110) regulations, rendering products adulterated.

Key violations include:
1.  **Temperature Control:** Failure to refrigerate "KEEP REFRIGERATED" carrot juice, observed unrefrigerated for 24 hours, and inadequate refrigeration space. (21 CFR 110.80(b)(3))
2.  **HACCP Plan:** Absence of a written hazard analysis and HACCP plan for carrot, pineapple, and other juices, and failure to include a 5-log reduction control for pertinent microorganisms like *Clostridium botulinum*. (21 CFR 120.7(a), 120.8(a), 120.24(a))
3.  **Sanitation Monitoring:** Inadequate monitoring of sanitation conditions. (21 CFR 120.6(h), 21 CFR Part 110)
    *   **Hygienic Practices:** Employees observed with torn gloves and consuming food in the production area. (21 CFR 110.10(b)(5), (8))
    *   **Cross-Contamination:** Unidentified individuals in the production area,

## Related Officers

- [Otto D. Vitillo](https://www.keypedia.com/people/otto-d-vitillo/362f7863-2591-40bd-8680-b59819da4798)

Company: https://www.keypedia.com/companies/juices-enterprises-inc/803981ff-589a-44bf-bf38-16b4371641c7

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d