FDA WARNING_LETTER - Kohyo America, Inc. - September 20, 2019

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection at Kohyo America, Inc. from September 16-20, 2019, following a previous inspection on August 22, 2017. The inspections aimed to assess compliance with section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) and 21 CFR part 1 subpart L. During the most recent inspection, FDA found that Kohyo America, Inc. was not in compliance with FSVP requirements for frozen baked eggs/atsuyaki tamago manufactured by Ahjikan Co., LTD. (Shizuoka Factory), Japan, specifically lacking an FSVP for this product. This significant violation was consistent with findings from the 2017 inspection, where the firm also failed to develop an FSVP for this and other imported food products. The firm's September 24, 2019, response, proposing to hire a consultant and take training, was deemed inadequate due to a lack of supporting documentation, and the firm continues to import the product. Kohyo America, Inc. must take prompt action to correct these violations and respond in writing within fifteen working days with detailed corrective actions and supporting documentation. Failure to comply may result in refusal of admission for the product, detention without physical examination (DWPE), and prohibition of importation under section 301(zz) of the FD&C Act.