The FSVP regulation requires that importers perform certain risk‐based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. More specifically, the company should have performed a hazard analysis on the frozen atsuyaki tamago product (a traditional Japanese multi-layered omelet).
So what hazards would one need to consider. First, Salmonella if the product was not properly cooked. Then, Listeria contamination would be a hazard to consider for potential cross contamination in the post-process environment. Depending on what else the facility processed, allergens may also be a hazard requiring control.
WARNING LETTER
Kohyo America, Inc.
MARCS-CMS 593593 — December 23, 2019
Recipient:
Hirotaka Isida
President
Kohyo America, Inc.
2730 W. Carson Street, Ste 245
Torrance, CA 90501
United States
Issuing Office:
Division of West Coast Imports
United States
WARNING LETTER
December 23, 2019
Re: CMS #593593
Dear Mr. Hirotaka Isida:
On September 16, 2019, the Food and Drug Administration (FDA) initiated a Foreign Supplier Verification Program (FSVP) inspection at Kohyo America, Inc. located at 2730 W. Carson Street, Ste 245, Torrance, CA 90501. The inspection concluded on September 20, 2019. We also conducted an inspection on August 22, 2017. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L.
The FSVP regulation requires that importers perform certain risk‐based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food‐safety‐modernization‐act‐fsma/fsma‐final‐ruleforeign‐supplier‐verification‐programs‐fsvp‐importers‐food‐humans‐and‐animals.
During the most recent inspection, we found that you 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. Your firm does not have an FSVP for this product. Because of this significant violation, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations.
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.
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.
The above violation is not intended to be an all‐inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.
You should take prompt action to correct the above violation. If you do not promptly correct this violation, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of frozen baked egg/atsuyaki tamago manufactured by Ahjikan Co., LTD. We may place this food on detention without physical examination (DWPE) when you import the products. You can find DWPE information relating to FSVP in Import Alert #99‐41 at http://www.accessdata.fda.gov/cms_i a/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your revised FSVP, records to demonstrate implementation of your FSVP, and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: Debbie Giang, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Compliance Officer Giang via phone at (562) 256‐9235 or via email at debbie.giang@fda.hhs.gov. Please reference CMS #593593 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Sincerely,
/S/
Dan R. Solis
Program Division Director
Division of West Coast Imports
WARNING LETTER
Kohyo America, Inc.
MARCS-CMS 593593 — December 23, 2019
Recipient:
Hirotaka Isida
President
Kohyo America, Inc.
2730 W. Carson Street, Ste 245
Torrance, CA 90501
United States
Issuing Office:
Division of West Coast Imports
United States
WARNING LETTER
December 23, 2019
Re: CMS #593593
Dear Mr. Hirotaka Isida:
On September 16, 2019, the Food and Drug Administration (FDA) initiated a Foreign Supplier Verification Program (FSVP) inspection at Kohyo America, Inc. located at 2730 W. Carson Street, Ste 245, Torrance, CA 90501. The inspection concluded on September 20, 2019. We also conducted an inspection on August 22, 2017. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1 subpart L.
The FSVP regulation requires that importers perform certain risk‐based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food‐safety‐modernization‐act‐fsma/fsma‐final‐ruleforeign‐supplier‐verification‐programs‐fsvp‐importers‐food‐humans‐and‐animals.
During the most recent inspection, we found that you 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. Your firm does not have an FSVP for this product. Because of this significant violation, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations.
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.
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.
The above violation is not intended to be an all‐inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.
You should take prompt action to correct the above violation. If you do not promptly correct this violation, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of frozen baked egg/atsuyaki tamago manufactured by Ahjikan Co., LTD. We may place this food on detention without physical examination (DWPE) when you import the products. You can find DWPE information relating to FSVP in Import Alert #99‐41 at http://www.accessdata.fda.gov/cms_i a/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your revised FSVP, records to demonstrate implementation of your FSVP, and any additional information that you wish to supply relevant to your compliance with the FSVP regulation. If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: Debbie Giang, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Compliance Officer Giang via phone at (562) 256‐9235 or via email at debbie.giang@fda.hhs.gov. Please reference CMS #593593 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Sincerely,
/S/
Dan R. Solis
Program Division Director
Division of West Coast Imports
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