FDA warning letter to California rice noodle maker cites Listeria spp. swabs and unvalidated B. cereus limits

On October 27, 2026, FDA posted a September 22, 2026 warning letter to Rama Food Manufacture Corp., which makes ready-to-eat (RTE) rice noodles at two facilities in Ontario, California. FDA inspected both sites from January 27 through February 26, 2026 and cited serious violations of the CGMP and preventive controls rule in 21 CFR part 117. FDA environmental swabs found Listeria innocua and Listeria grayi at the S Parco Avenue facility and L. grayi at the E Cedar Street facility. The letter notes these species are not human pathogens but can indicate inadequate sanitation and conditions that support the growth of Listeria monocytogenes.

According to the letter, the firm's revised time and temperature limits would still let soaked rice spend up to 3.5 cumulative hours above 70°F, while FDA recommends a three-hour maximum to control Bacillus cereus, and the firm had not provided the challenge and validation studies it promised. FDA's finished-product samples had pH values above 4.4, the level the letter uses for supporting L. monocytogenes growth, and water activity of 0.98 to 1.00, and packaged noodles cooled slowly in storage, in one case by only 4.5°F over 26 hours. FDA also said the S Parco Avenue facility had not identified recontamination with environmental pathogens as a hazard and noted that verification must include environmental monitoring when it is a hazard requiring a preventive control (21 CFR 117.165(a)(3)).