FDA WARNING_LETTER - Cali Rice Valley Inc. - January 21, 2020

The FDA inspected a San Francisco seafood and noodle facility from November 2019 to January 2020, identifying serious violations of the CGMP & PC rule (21 CFR Part 117) and seafood HACCP regulation (21 CFR Part 123). Ready-to-eat (RTE) rice and wheat noodles, and RTE Shrimp Rice Rolls, were deemed adulterated (21 U.S.C. § 342(a)(4)) due to insanitary conditions. Instant Noodles and Ready Cooked Noodles were also adulterated (21 U.S.C. § 342(c)) for containing unsafe, undeclared color additives like FD&C Yellow No. 5. Violations included failure to conduct hazard analyses, implement preventive controls, or prepare a food safety plan for RTE noodles. CGMP deficiencies involved inadequate plant construction (condensation), poor employee hygiene, pest exclusion failures (rodents, birds, structural gaps), and improper cleaning/sanitizing. The firm lacked a HACCP plan for RTE Shrimp Rice Rolls to control pathogens, allergens, and intolerance-causing substances. Additionally, numerous products were misbranded (21 U.S.C. § 343) due to significant labeling issues: undeclared major food allergens (milk, wheat, eggs), failure to declare artificial coloring, incorrect net quantity of contents, incomplete ingredient lists, missing or improperly formatted nutrition information, and non-compliance with foreign language labeling and statements of identity. The FDA mandates prompt corrective action within fifteen business days, with a written response detailing prevention steps, warning of potential regulatory actions like seizure or injunction, and reinspection fees for non-compliance.