FDA WARNING_LETTER - Mobilia Fruit Farms Inc. albo dba Arrowhead Wine Cellars - November 08, 2012

The FDA inspected Mobilia Fruit Farms, Inc.'s juice processing facility from October 24 to November 8, 2012, finding serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 120), Current Good Manufacturing Practice (cGMP) regulations (21 CFR Part 110), and food labeling regulations (21 CFR Part 101).

Key violations include: - **Juice HACCP:** No HACCP plan for Cherry Juice to control *Listeria monocytogenes*, metal, and glass fragments. The Grape Juice HACCP plan failed to list glass breakage as a hazard and lacked control measures for identified hazards. Sanitation standard operating procedure records were not maintained for several areas (e.g., cross connections, handwashing, pest exclusion) and existing records were inadequate, with uninitialed completed tasks. - **cGMP:** Pasteurized shelf-stable juice products were deemed adulterated due to insanitary conditions. - **Labeling:** Both Grape and Cherry Juice labels were misbranded. They lacked required nutrition information (e.g., Percent Daily Value for Total Fat and Sodium), failed to include "Not a significant source of ____" statements, and did not bear the net quantity of contents in fluid ounces. The Grape Juice label also lacked the manufacturer's name and place of business. Furthermore, the "100% PURE" statement did not