WARNING LETTER
Visvita Corporation
MARCS-CMS 633747 —
August 23, 2022
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Kyungnam (NMI) Kim
Recipient Title
Owner & CEO
Visvita Corporation
628 North Gilbert Street
Fullerton
,
CA
92833
United States
INFO@CHIMEXPRODUCE.COM
Issuing Office:
Division of West Coast Imports
United States
August 23, 2022
WARNING LETTER
C/c Kiyoul (Kevin)(NMI) Choi, Logistics Manager and FSVP Contact
Re: CMS # 633747
Dear Mr. Kyungnam Kim:
On April 26, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Visvita Corporation located at 13744 Excelsior Dr, Santa Fe Springs, CA 90670-5102. We also conducted an inspection on July 16 and 17, 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 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 the foods you import. Because of these significant violations, 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 April 26, 2022. Your response stated that you retained the services of a third-party consulting firm,
(b)(4)
to assist you with the creation of your FSVP and stated that it would take approximately 60 days to come into compliance with the FSVP regulation. We are unable to evaluate the adequacy of your response because you did not provide any supporting documentation or describe specific steps or actions that you or your consulting firm have taken to comply with the FSVP regulation.
Your significant violation 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 any foods that you import, including the following foods:
Visvita Chia Drink - Guanabana Flavour imported from
(b)(4)
, located in
(b)(4)
.
Aloe Vera Drink - Pomegranate Flavor imported from
(b)(4)
, located in
(b)(4)
.
Cold Brew Coffee Powder imported from
(b)(4)
, located in
(b)(4)
.
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.
This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, 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 the food you import for which you appear to be in violation of section 805. We may place the foods you import into the United States on detention without physical examination (DWPE) when you import the foods. 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 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 working 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: Sandra K. Wangen, Compliance Officer, Division of West Coast Imports, 949 Market St, Suite 602, Tacoma, WA 98402. If you have any questions regarding this letter, you may contact Sandra K. Wangen via email at sandra.wangen@fda.hhs.gov. Please reference CMS # 633747 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/
Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports
Content current as of:
09/06/2022
Regulated Product(s)
Food & Beverages