FDA WARNING_LETTER - Jroll LLC - October 01, 2012

On November 19, 2012, the FDA issued a Warning Letter to Jroll LLC dba Sushi On The Roll following an inspection from September 4 to October 1, 2012, at their Medina, OH facility. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their sushi seafood products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to implement monitoring procedures:** The firm did not follow monitoring procedures for acidification of rice, thawing of fish/raw shellfish, packaging and labeling, and finished product refrigerated storage. Specifically, pH of wholesale sushi rice was not checked, thawing and storage temperatures were not continuously monitored, cooler visual checks were not performed twice daily, and ingredient labeling was not checked on every finished product package. (21 CFR 123.6(b) and (c)(4)) 2. **Inadequate critical limits:** The HACCP plan for "Raw Fish, Tuna, and Yellowtail Sushi Rolls Histamine Products" listed an inadequate critical limit for allergen control at the packaging and labeling CCP, stating only that packaged product must be labeled "raw." (21 CFR 123.6(c)(3)) 3. **Inappropriate corrective actions:** Corrective