- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameSeung Won Baek
- Daisy Global Trading Co
17777 Center Court Dr. N Ste 600
Cerritos, CA 90703-8575
- Issuing Office:
- Division of West Coast Imports
April 15, 2021
Re: CMS # 612999
Dear Mr. Seung Won Baek:
From November 18 through December 4, 2020, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Daisy Global Trading Co. located at 17777 Center Court Dr. N Ste 600, Cerritos, CA 90703-8575. We also conducted an inspection on February 8, 2019. 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 under 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-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your frozen oriental style udon imported from (b)(4), located in (b)(4); fresh Japanese style soba and fresh Japanese style udon imported from (b)(4), located in (b)(4); rice sticks imported from (b)(4), located in (b)(4); scorched rice imported from (b)(4) located in (b)(4); Buckwheat noodle (Zaru soba) imported from (b)(4) located in (b)(4); and Korean seasoned seaweed imported from (b)(4) located in (b)(4). Because of these significant issues, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of both the initial FSVP inspection on February 8, 2019 and the follow-up inspection on December 4, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
We acknowledge receipt of your response, dated December 29, 2020, in which you provided your written procedure regarding FSVPs for your imported products. Enclosed were six (6) FSVPs for the following foods: frozen oriental style udon, fresh Japanese style udon, roasted seasoned seaweed (Laver), Buckwheat noodle (Zaru Soba), scorched rice, and Korean biscuit (Rice stick). During the inspection, you also provided your firm’s FSVP Manual that addressed the documents required from your foreign suppliers: Supplier Letter of Guarantee, Supplier Approval Questionnaire, Hazard Analysis and Critical Control Points (HACCP) Plan, Liability Insurance, and Certificate of 3rd Party Audit. Your FSVP manual also listed the documents your firm must complete and verify for your foreign suppliers: Foreign Supplier Verification Activity Worksheet, FSVP Food Hazard Analysis Form, FSVP Foreign Supplier Evaluation Form, FSVP Supplier Re-evaluation Form, and FSVP Supplier List for Daisy Global Trading. Our review of your response finds that you have not addressed all the violations related to the food products you import, as further described in this letter.
Your significant violations of the FSVP regulation are as follows:
1. You did not meet the requirement to conduct and document (or obtain documentation of) one or more of the supplier verification activities listed in 21 CFR 1.506(e)(1)(i) through (iv) for each foreign supplier before importing the food and periodically thereafter as required by 21 CFR 1.506(e). Your December 29, 2020 response included six documents titled “FSVP-Foreign Supplier Evaluation.” You did not conduct and document or obtain documentation of one or more supplier verification activities before importing rice sticks imported from (b)(4); scorched rice imported from (b)(4); Buckwheat noodle (Zaru soba) imported from (b)(4); and Korean seasoned seaweed imported from (b)(4), all located in (b)(4). You also did not provide your documentation of the frequency with which the verification activity will be conducted, as required by 21 CFR 1.506(c).
2. You did not provide your documentation of the corrective action implementation, as required by 21 CFR 1.508. In your December 29, 2020 response, your document titled “FSVP-Foreign Supplier Evaluation” for your rice stick imported from (b)(4) includes a description under “corrective action needed” of “HACCP Plan, HA & PC, Allergen control Program Required”. Further, your hazard analysis identified allergens as a chemical hazard with justification stated as the product is processed in a facility that also processes peanut, egg, fish, tree nut, wheat, milk, and soybean. However, you have not verified that the supplier has an allergen control program in place. You did not document your corrective action implementation, as required by 21 CFR 1.508.
The above matters are 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.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in 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 the food products you import that appear to be in violation of section 805. We may place the foods you import 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_ia/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 (21 U.S.C. 331(zz)).
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 any 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 Debbie Giang via phone at (562) 256-9235 or via email at firstname.lastname@example.org. Please reference CMS #612999 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Lawton W. Lum
Acting Program Division Director
Division of West Coast Imports