Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3012577453.
Violations5
Issue DateSep 30, 2024
Product TypeFood & Beverages
StatusOpen
Letter Details
Firm
Miyajima Shoyu Co., Ltd.
Location
Satoru Iwamoto
Head of Myoken Factory
Miyajima Shoyu Co., Ltd.
1-18 Nakanosedor
Karatsu , Saga
847-0101
Japan
iwamoto@miyajima-soy.co.jp
FEI Number
3012577453
Country
Japan
Issue Date
September 30, 2024
Issuing Office
Center for Food Safety and Applied Nutrition
Product Type
Food & Beverages
Status
Open
Summary
Miyajima Shoyu Co., Ltd., a Japanese manufacturer of acidified foods exported to the United States, was found to have serious deviations from the Emergency Permit Control regulation (21 CFR Part 108) and the Acidified Foods regulation (21 CFR Part 114) during a May 2024 FDA inspection. The company failed to comply with mandatory requirements including proper registration and filing of process information as specified in 21 CFR 108.25 and Part 114 for processing acidified food products in hermetically sealed containers. The firm's written response to the inspection findings, submitted in June 2024, was deemed inadequate by the FDA.
Miyajima Shoyu Co., Ltd. FDA Warning Letter, September 30, 2024
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