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WARNING LETTER

SCO Koladen LLC MARCS-CMS 629661 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Wolfgang P. Steitz
Recipient Title
Owner/Manager
SCO Koladen LLC

751 N Canyons Pkwy
Livermore, CA 94551-9479
United States

Issuing Office:
West Coast Import District Compliance Branch - Team 2 (WCID-CB)

United States

April 14, 2022

WARNING LETTER

Re: CMS # 629661

Dear Mr. Wolfgang P. Steitz:

On December 1 to December 7, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of SCO Koladen LLC located at 751 N Canyons Pkwy, Livermore, CA 94551-9479. We also conducted an inspection on June 21 to June 24, 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 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 email response dated December 20, 2021 to the Form FDA 483a in which you indicated that you would develop and implement an FSVP on or before March 11, 2022. However, we are unable to evaluate the adequacy of your response because to date you have not provided FSVP records or additional information regarding your corrections.

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, maintain, and follow an FSVP for any of the foods you import, including:

• (b)(4) Milk Chocolate with Almonds imported from (b)(4), located in (b)(4)
• (b)(4) imported from (b)(4), located in (b)(4)
• Advent Calendar with chocolate pieces imported from (b)(4), located in (b)(4)

During our inspection you provided three documents which you obtained from your foreign suppliers: a “FSMA” document for (b)(4); an Audit Report for (b)(4); and a Food Safety Plan for (b)(4). However, the documents that are relevant to an FSVP are incomplete, and you did not provide a record of your review of the relevant documents or explain how they would apply to your FSVP program. Thus, these documents do not constitute an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a).

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.

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: Lin Liu, 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 Mr. Lin Liu via email at lin.liu@fda.hhs.gov. Please reference CMS # 629661 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.

Sincerely,
/S/

Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports

 
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