WARNING LETTER
SeaSnax
MARCS-CMS 605886 —
April 17, 2020
Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Yong Bin Yuk
Recipient Title
CEO
SeaSnax
5976 East Slauson Avenue
Commerce
,
CA
90040
United States
Issuing Office:
Division of West Coast Imports
United States
WARNING LETTER
April 17, 2020
Re: CMS # 605886
Dear Mr. Yong Bin Yuk:
On February 25, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at SeaSnax LLC, located at 5976 East Slauson Avenue, Commerce, California 90040. We also conducted an inspection on September 19, 2018. 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-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 SeaSnax - Original (aka SeaSnax Classic or Seasoned Laver), SeaSnax - Grab & Go (aka SeaSnax G&G or Seasoned Laver), and SeaSnax - Raw (aka Roasted Laver) products you import from your foreign supplier
(b)(4)
; and the Chomperz Crunchy Seaweed Chips - Original you import from your foreign supplier
(b)(4)
. You did not have FSVPs for these products. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of both the initial FSVP inspection and the follow-up inspection on February 25, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations. We have not received your response to the Form FDA 483a.
Your significant violations of the FSVP regulation are as follows:
You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for each of the following foods:
• SeaSnax - Original (aka SeaSnax Classic or Seasoned Laver), SeaSnax - Grab & Go (aka SeaSnax G&G or Seasoned Laver), and SeaSnax - Raw (aka Roasted Laver) products manufactured by
(b)(4)
.
• Chomperz Crunchy Seaweed Chips - Original manufactured by
(b)(4)
.
The above violations 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.
You should take prompt action to correct the above violations. If you do not promptly correct these violations, 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 SeaSnax - Original (aka SeaSnax Classic or Seasoned Laver), SeaSnax - Grab & Go (aka SeaSnax G&G or Seasoned Laver), and SeaSnax - Raw (aka Roasted Laver) products imported from
(b)(4)
; and Chomperz Crunchy Seaweed Chips - Original imported from
(b)(4)
. We may place these foods from the identified foreign suppliers on detention without physical examination (DWPE) when you import these 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.
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 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: James R. Ahlrep, Compliance Officer, Division of West Coast Imports, 1 World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact James Ahlrep via email at james.ahlrep@fda.hhs.gov. Please reference CMS # 605886 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
Content current as of:
05/05/2020
Regulated Product(s)
Food & Beverages