FDA WARNING_LETTER - Home Grown Cellars - September 21, 2015

The FDA inspected Lehman Family Farms, Inc. dba Home Grown Cellars in Madera, CA, from August 21 to September 21, 2015, revealing serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120). The firm is not exempt from HACCP regulations because it sells juice to both wholesale and retail customers. Consequently, all juice products, including 100% pomegranate juice, apple juice, and 100% pomegranate frozen juice bars, are subject to these regulations.

Violations include: 1. Failure to validate critical limits in the HACCP plan for "Pomegranate Juice/Ice Wink Juice Bars" to achieve a 5-log reduction of pertinent microorganisms, as required by 21 CFR 120.24(a). 2. The revised HACCP plan for "Pomegranate Juice/Ice Wink Juice Bars" does not list vegetative bacterial pathogens as reasonably likely food safety hazards, violating 21 CFR 120.8(b)(1). 3. Failure to maintain sanitation monitoring records for various areas, including food contact surfaces, cross-contamination prevention, handwashing facilities, protection from contaminants, toxic compound control, employee health, and pest exclusion, as required by 21 CFR 120.6(c).

These violations render the juice products adulterated under section 4