Neukom Groves, Inc. – FDA Warning Letter, Feb 24, 2012

On May 17, 2012, the FDA issued a Warning Letter to Neukom Groves, Inc. following an inspection of their juice processing facility in Zephyrhills, FL, from February 6-24, 2012. The inspection revealed serious deviations from FDA's juice processing regulation (21 CFR Part 120), rendering their Orange, Grapefruit, and Tangerine 100% juice products in violation.

Key violations include: 1. **HACCP Plan Deficiency (21 CFR 120.24(a), (b), (c)):** The HACCP "Plan Summary" failed to list control measures to consistently achieve a 5-log reduction in pertinent microorganisms for the product's shelf life. The firm could not assure that their processing methods matched those in their "Fresh Squeezed Juice Log Reduction Chart" studies or that the combination of methods achieved the required 5-log reduction. 2. **Inadequate HACCP Monitoring (21 CFR 120.8(b)(4)):** The HACCP plan for citrus juices listed a critical limit of minimum 200 ppm acid sanitizer with specific brush and rinse times at the "acid brush wash and rinse" CCP. However, the monitoring procedure only included testing sanitizer concentration at the beginning of operation and did not include monitoring for sanitizer contact time or water rinse time. Firm records also