Cali Rice Valley, Inc.
Outcome
A federal court entered a consent decree of permanent injunction against Cali Rice Valley, Inc. in December 2023, barring the Antioch, California ready-to-eat rice noodle and bakery products manufacturer from producing food until in compliance with FDCA, after four FDA inspections (2019–2022) documented persistent hazard analysis failures and adulteration risk — many violations were repeat findings.
Details
Cali Rice Valley, Inc. — Adulterated RTE Rice Noodles / Consent Decree (2023)
Outcome: A federal court entered a consent decree of permanent injunction against Cali Rice Valley, Inc. in December 2023, barring the Antioch, California manufacturer of ready-to-eat rice noodles and bakery products from all production until FDA compliance is achieved, after four FDA inspections between 2019 and 2022 documented recurring failures in hazard analysis and preventive controls — many of them repeat violations.
Cali Rice Valley, Inc. operates a food manufacturing facility in Antioch, California (previously located in San Francisco) and produces ready-to-eat rice noodles in retail and bulk packaging, along with various bakery products. The company is owned and managed by Cuong T. Do. FDA conducted inspections of the firm's facilities in 2019, 2020, 2021, and 2022. Inspection findings in each year documented violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117). Critically, many violations found in later inspections were repeats of deficiencies that had been cited in earlier inspections, indicating that the firm's corrective action responses were either insufficient or not implemented.
The DOJ filed a civil complaint on October 11, 2022, in the Eastern District of California at the request of the FDA, alleging that the defendants violated the FDCA by manufacturing and distributing adulterated food products — specifically, failing to adequately conduct hazard analyses to identify food safety hazards, failing to establish and implement adequate preventive controls, and failing to validate those controls where required. These failures left the firm's RTE rice noodle products at risk of contamination by disease-causing bacteria.
The consent decree of permanent injunction, entered December 2023, requires Cali Rice Valley and Cuong T. Do to cease all manufacturing, processing, packing, holding, and distributing of food until they have corrected all violations, received FDA inspection, and received written authorization from FDA to resume production.
Primary Source: District Court Enjoins California Food Company from Manufacturing and Distributing Adulterated Food Products | DOJ
How Crucible Prevents This
Four FDA inspections over four years (2019–2022) at the same facility found the same categories of violations — inadequate hazard analysis, failure to implement preventive controls — without the firm achieving lasting compliance. Crucible's DECISIONS log with recurring session-gate review converts each inspection finding into a documented open action item that must be closed before the next production session proceeds. A pattern of repeat violations on an identical issue would be impossible to maintain unnoticed in a Crucible-enforced environment: each unresolved finding from the prior inspection would block the session gate.
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