As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent.

Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

Kohyo America, Inc. — Torrence, CA
The Food and Drug Administration sent a warning letter dated Dec. 23, 2019, to Mr. Hirotaka Isida, President of Kohyo America, Inc.

During a Foreign Supplier Verification Program (FSVP) inspection at Kohyo America, Inc on Sept. 16, 2019, investigators found that they were not in compliance with the requirements of 21 CFR part 1 subpart L for the frozen baked eggs/atsuyaki tamago manufactured by Ahjikan Co., LTD, Shizuoka Factory, Japan.

In response to this deviation, the FDA issued an FDA-483a Inspectional Observations form that lists deviations observed at the facility.

The violations noted by the FDA:

  1. We acknowledge receipt of your response dated September 24, 2019, which was received by the Division of West Coast Imports on October 2, 2019. You advised that within five months, you will hire a consultant and take FSVP training courses in order to develop an FSVP. Your response cannot be evaluated because you did not provide supporting documentation. We also note that you are continuing to import frozen baked eggs/atsuyaki tamago.”
  2. Our finding during the September 16 to 20, 2019 inspection was consistent with our finding during the previous inspection of your firm. During an August 22, 2017 inspection, we also found that your firm was not in compliance with section 805 of the FD&C Act because your firm did not develop an FSVP for frozen baked egg/atsuyaki tamago manufactured by Ahjikan Co., LTD, in Japan or other food products that you import.”

A complete list of the violations can be found in the FDA’s warning letter.

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