Maruhachi Muramatsu Inc., Danchi Factory

Warning LetterOpen

Mr. Masahito Kawamura Managing Director Maruhachi Muramatsu Inc., Danchi Factory 1281-8 Souemon Yaizu , Shizuoka 425-0065 Japan masahito.kawamura@08m.co.jpIssued Oct 17, 2024Human Foods Program

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations3

Issue DateOct 17, 2024

Product TypeFood & Beverages

StatusOpen

Letter Details

Firm: Maruhachi Muramatsu Inc., Danchi Factory
Location: Mr. Masahito Kawamura Managing Director Maruhachi Muramatsu Inc., Danchi Factory 1281-8 Souemon Yaizu , Shizuoka 425-0065 Japan masahito.kawamura@08m.co.jp
FEI Number: N/A
Country: Japan
Issue Date: October 17, 2024
Issuing Office: Human Foods Program
Product Type: Food & Beverages
Status: Open

Summary

Maruhachi Muramatsu Inc.'s Danchi Factory, a seafood processing facility in Japan, failed to comply with seafood HACCP regulations (21 CFR 123) during an FDA inspection in April 2024, resulting in their refrigerated reduced oxygen packaged (ROP) skipjack tuna soup base product being deemed adulterated. The company's HACCP plan was found to lack adequate critical limits as required by regulation, and their May 2024 corrective action response was deemed insufficient to address the violations. The FDA determined that the product may have been rendered injurious to health due to improper preparation, packing, or holding conditions resulting from non-compliant HACCP procedures.

Maruhachi Muramatsu Inc., Danchi Factory FDA Warning Letter, October 17, 2024