WARNING LETTER
Woobo LLC dba Purunchon Inc.
MARCS-CMS 611995 —
January 20, 2021
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Francis Kim
Recipient Title
President
Woobo LLC dba Purunchon Inc.
2297 Ardemore Dr.
Fullerton
,
CA
92833
United States
Issuing Office:
Division of West Coast Imports
United States
WARNING LETTER
January 20, 2021
Re: CMS # 611995
Dear Mr. Francis Kim:
From September 11 through 16, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection for Woobo LLC dba Purunchon, Inc., located at 2297 Ardemore Dr., Fullerton, CA 92833. We also conducted inspections on December 13, 2018 and August 9, 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-supplierverification-programs-fsvp-importers-food-humans-and-animals.
During our most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your Napa cabbage kimchi imported from
(b)(4)
; soybean paste imported from
(b)(4)
; and
(b)(4)
imported from
(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 the initial FSVP inspection on December 13, 2018, the follow-up inspection on August 9, 2019, and the most recent inspection on September 16, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations. In addition, FDA held a meeting with you on May 26, 2020 to discuss our findings from our inspection conducted on August 9, 2019. We acknowledge receipt of your email response dated September 29, 2020, and we address your response below.
Your significant violations of the FSVP regulation are as follows:
1. 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:
a. Napa cabbage kimchi imported from
(b)(4)
b. Soybean paste imported from
(b)(4)
c.
(b)(4)
imported from
(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 them, 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 Napa cabbage kimchi imported from
(b)(4)
; soybean paste imported from
(b)(4)
; and
(b)(4)
imported from
(b)(4)
. We may place the foods from the identified foreign suppliers 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.
In addition to the above violations, we also have the following comments:
• You must establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505, and document your use of these procedures, as required by 1.506(a)(1). You provided FDA with a copy of your FSVP for the
(b)(4)
product you import from your foreign supplier
(b)(4)
. This FSVP includes a document titled “Approved Supplier Employee Acknowledgement,” which states that you “will not purchase any products from any suppliers that are not identified as approved suppliers pursuant to this program” and that the employees identified in this document “acknowledge that they will only purchase products from those approved suppliers who are identified in this program.” While one of your employees signed this document, the documentation you provided does not specify what procedures your employee(s) should follow to ensure that you import foods only from approved suppliers, nor did you provide documentation of your use of these written procedures.
• In your email dated September 29, 2020, you provided a document titled “Procedure for Foreign Supplier Verification (for
(b)(4)
from
(b)(4)
),” which states that “we will be visiting supplier at least
(b)(4)
to monitor and collect the food safety information to make sure our evaluation is verified.” However, this appears to be inconsistent with the FSVP you provided for this product and foreign supplier, which states that your verification activities include “3rd party Audit” to be conducted every
(b)(4)
. If you have determined that an onsite audit performed
(b)(4)
by a qualified auditor is an appropriate foreign supplier verification activity for your foreign supplier, you should update your FSVP to reflect this.
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: Deborah W. Hsu, 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 Deborah Hsu via email at deborah.hsu@fda.hhs.gov. Please reference CMS # 611995 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/
Gordon Chu
Acting Program Division Director
Division of West Coast Import
Content current as of:
02/09/2021
Regulated Product(s)
Food & Beverages