FDA WARNING_LETTER - Nu Garden, LLC

The FDA inspected Nu Garden, LLC's seafood processing facility in Taos, New Mexico, on December 9, 2011, and found significant violations of the seafood Hazard Analysis and Critical Control Points (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). The firm failed to conduct a hazard analysis and implement a written HACCP plan for tuna salads/sandwiches and sushi rolls (salmon, shrimp, tuna) to control food safety hazards like pathogen growth and major food allergens, as required by 21 CFR 123.6(a) and (b). Additionally, Nu Garden, LLC did not maintain sanitation control records for critical areas such as water safety, prevention of cross-contamination, handwashing facilities, protection of food contact surfaces, proper chemical use, and employee health conditions, violating 21 CFR 123.11(c). These deficiencies render the firm's products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The FDA requires a written response within 15 working days detailing corrective actions, including submission of a HACCP plan and other documentation. Failure to correct these violations may result in further action, including product seizure and injunction.