FDA WARNING_LETTER - Marukyo Co., Ltd. - September 14, 2018

On March 14, 2019, the FDA issued a Warning Letter to Marukyo Co., Ltd. following an inspection of their low-acid canned food (LACF) facility in Japan on September 13-14, 2018. The inspection revealed serious deviations from the Emergency Permit Control regulation (21 CFR 108) and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation (21 CFR 113).

The primary violation identified was the firm's failure to register and file scheduled processes with the FDA for various LACF products, including Dorayaki, prior to manufacturing, packing, and distributing them. The Dorayaki products, with pH levels above 4.6 and water activity (Aw) values above 0.85, are considered low-acid foods. They are packaged in reduced oxygen packaging and stored at ambient temperatures for a period before being frozen for shipment to the U.S. The labeling instructs consumers to "KEEP REFRIGERATED," but the firm's handling practices do not consistently maintain refrigeration.

The FDA deemed the firm's responses to the FDA-483 inadequate, noting that while low water activity prevents *Clostridium botulinum* spores from germinating, it does not kill them. The firm's revised HACCP plan was also found insufficient.

The Warning Letter states that these violations render the LACF