Marukyo Co. Ltd. of Japan is on notice from the FDA because of significant deviations from the Emergency Permit Control regulation, and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation.


Staff from the Food and Drug Administration inspected the Hatagasaki, Japan location of Marukyo Co. Ltd. on September 13 through 14, 2018. They discovered the “serious violations” regarding the firm’s Emergency Permit Control, and Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers, according to a March 14 warning letter made public by the FDA in recent days.

Marukyo Co. Ltd. manufactures, processes, and distributes a variety of Low-Acid Canned Food (LACF) Dorayaki products; which, “in various flavors consist of red bean paste sandwiched between two baked wheat cakes.”

“As a manufacturer of LACF products intended for export to the United States, you are required to comply with the Federal Food Drug and Cosmetic Act (the Act) and the Federal regulations relating to the processing of low-acid foods packaged in hermetically sealed containers,” according to the letter sent to Mr. Hiroo Sumi, President of Marukyo Co., Ltd.

Although the firm responded to the FDA on October 1, 2018, via email including a description of the corrective actions taken and responded to the FDA’s follow-up questions on December 6, 2018, the FDA’s evaluation revealed that the firm’s responses were not adequate.

The FDA noted the following, unresolved, significant violations:

  • First, the firm failed to file the scheduled processes for each low-acid food in each container size to comply, with the FDA. These filings must occur not later than 60 days after registration and prior to the packing of a new product. According to the FDA, “these must include the processing method, type of retort or other thermal processing equipment employed, minimum initial temperatures, times and temperatures of processing, sterilizing value, or other equivalent scientific evidence of process adequacy, critical control factors affecting heat penetration, and source and date of the establishment of the process, for each product in each container size,” for LACF products. During the inspection, the FDA determined that the firm has manufactured, packed and distributed various LACF products without registering and filing scheduled processes with the FDA.
  • Second, the FDA noted that the firm seals their finished products in reduced oxygen packaging, creating a hermetic seal. The firm stores their finished products at ambient room temperature after packaging, before being transported to a refrigerated warehouse. The firm explained to the FDA investigator that the products are then shipped frozen to the U.S. and further explained that when the frozen product arrives in the U.S., it is thawed, distributed refrigerated and stored in retail markets at ambient or refrigerated temperatures. The FDA noted, “Your labeling states ‘KEEP REFRIGERATED and consume within 90 days’. Consequently, it appears that your firm is not following the handling instructions on the labels of your products, in that you are not continuously maintaining the products under refrigerated conditions.”
  • Third, regarding the firm’s products as low-acid foods and subject to requirements under the Act, “during our previous inspection conducted on November 14-15, 2013, you provided pH values for your Dorayaki products,” as the firm’s products fall under the FDA’s Low Acid Canned Foods (LACF) regulations. The firm needs to have scheduled processes developed by a Process Authority.
  • Additionally, the firm’s September 30, 2018, response to FDA inspection notes described the firm’s corrective measures, included modifying their label, and adding a requirement for refrigerated storage of their product. According to the warning letter, the FDA replied on November 27, 2018 with questions regarding the specific time limit from packaging to refrigeration and, whether there are any established critical control points (CCPs) in the firm’s HACCP plan for their Dorayaki products to cover labeling, or refrigerated storage or freezing after packaging while held at the firm’s facility.
  • The FDA also requested documents such as the firm’s revised HACCP plan; “You responded on December 6, 2018, to our questions and provided documents including your revised HACCP plan.” The firm also stated that they thought there was no risk of Clostridium botulinum in their product because of their water activity values. The FDA noted that “although low water activity prevents the spores from germinating, it does not kill Clostridium botulinum. Commercial sterility is achieved by controlling the water activity and the application of heat to kill vegetative pathogens.”

Food companies are given 15 working days to respond to FDA warning letters. “You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by FDA without further notice, including, without limitation, seizure and injunction,” according to the warning letter.

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