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WARNING LETTER

Royal International Trading LLC MARCS-CMS 606915 —


Delivery Method:
United Parcel Service
Product:
Food & Beverages

Recipient:
Recipient Name
Zhaokai Lao
Recipient Title
Owner
Royal International Trading LLC

1105 W. Olympic Blvd
Montebello, CA 90640
United States

Issuing Office:
Division of West Coast Imports

United States


May 27, 2020

WARNING LETTER

Re: CMS # 606915

Dear Mr. Zhaokai Lao,

On March 12th and 17th, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at Royal International Trading LLC 1105 W. Olympic Blvd, Montebello, CA 90640. This inspection was 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 inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for: (b)(4) Mushroom, imported from your foreign supplier (b)(4) Mushroom, imported from your foreign supplier (b)(4) and (b)(4), imported from your foreign supplier (b)(4). Your firm 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 FSVP inspection, our investigator provided you with Form FDA 483a, FSVP Observations.

We acknowledge receipt of your response on March 24 wherein you attached records from (b)(4), documenting a HACCP audit of (b)(4) for mushroom production. We are unable to evaluate the adequacy of this response because you did not provide your review of these documents or how they would apply to your FSVP program. We also acknowledge receipt of your email response dated April 8, 2020, wherein you attached a document labeled “HACCP Plan (b)(4),”. Although the document mentions requirements for a hazard analysis and supplier evaluation, there are no details regarding these or other FSVP requirements for any specific products. You did not provide any details or timeframes for when you will develop and implement FSVPs for any of the products you import. Therefore, we are unable to evaluate the adequacy of your response. We note that, to the extent you may be trying to rely on the aforementioned HACCP plans to fulfill your FSVP requirements, you must comply with the evaluation for foreign supplier approval and verification activities set forth in 21 CFR 1.505. Furthermore, in accordance with 21 CFR 1.506, you must establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved based on the evaluation conducted under §1.505 (or, when necessary and appropriate, on a temporary basis from unapproved foreign suppliers whose foods you subject to adequate verification activities before importing the food). You must document your use of these procedures.

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, your firm did not develop FSVPs for each of the following foods:
    o (b)(4) Mushroom, imported from your foreign supplier (b)(4).
    o (b)(4) Mushroom, imported from your foreign supplier (b)(4).
    o (b)(4), imported from your foreign supplier (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 (b)(4) Mushroom imported from your foreign supplier (b)(4) Mushroom imported from your foreign supplier (b)(4), and (b)(4) imported from your foreign supplier (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.

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: Courtney Warren, Compliance Officer, Division of West Coast Import, 1201 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, you may contact Courtney Warren via email at Courtney.Warren@fda.hhs.gov. Please reference CMS # 606915 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

 
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