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WARNING LETTER

April 14, 2023

Re: CMS 652935

Dear Mr. Chiu:

On November 4 and November 17, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Milky Way International Trading Corporation located at 15203 Shoemaker Avenue, Norwalk, CA 90650-6858. We also conducted FSVP inspections from September 14 to September 15, 2017, and from August 25, 2020 to September 10, 2020. 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 from the foreign suppliers indicated in the attached list and for Strawberry Syrup and Blueberry Syrup imported from (b)(4), and Canned Coconut Cream imported from (b)(4). 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 November 28, 2022, in which you stated that you have received the observation and will address the corresponding action. We are unable to evaluate the adequacy of any corrective actions because you have not provided any supporting documentation demonstrating your planned or completed corrective actions. To date, no additional FSVP documents have been received by FDA.

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 the following foods:

• Mushroom, Common (Agaricus Bisporus), Pieces And Stems, Sliced imported from (b)(4)
• Artichoke (Microgreen) and Artichoke (Leaf & Stem Vegetable) imported from (b)(4), located in (b)(4)
• Asparagus (Microgreen) and Asparagus (Leaf & Stem Vegetable) imported from (b)(4), located in (b)(4)
• Jerusalem Artichoke (Root & Tuber Vegetable) imported from (b)(4), located in (b)(4)
• Corn (Vegetable) imported from (b)(4), located in (b)(4)
• Orange (Citrus) imported from (b)(4), located in (b)(4)
• Pear (Core Fruit) imported from (b)(4), located in (b)(4)
• Peach (Pit Fruit) imported from (b)(4), located in (b)(4)
• Asparagus (Microgreen) and Asparagus (Leaf & Stem Vegetable) imported from (b)(4), located in (b)(4)
• Orange (Citrus) imported from (b)(4), located in (b)(4)
• Orange (Citrus) imported from (b)(4), located in (b)(4)
• Fruit Cocktail, Mixed Fruits imported from (b)(4), located in (b)(4)
• Peach, Jam, Jelly, Preserves, Marmalade, Butter Or Candied imported from (b)(4), located in (b)(4)
• Other Fruits And Subtropical/Tropical Fruit, Mixed, Toppings And Syrups imported from (b)(4), located in (b)(4)
• Mixed Fruit, N.E.C. imported from (b)(4), located in (b)(4)
• Peach (Pit Fruit) imported from (b)(4), located in (b)(4)
• Horseradish, Prepared imported from (b)(4), located in (b)(4)
• Bamboo Shoots (Microgreen) and Bamboo Shoots (Leaf & Stem Vegetable) imported from (b)(4), located in (b)(4)
• Heart Of Palm (Leaf & Stem Vegetable) imported from (b)(4), located in (b)(4)

2. You did not meet the requirements to perform foreign supplier verification activities in accordance with 21 CFR 1.506 for the products you import. Specifically, you did not meet the requirement to, before importing a food from a foreign supplier, determine and document which verification activity or verification activities, and the frequency with which such verification activity or activities must be conducted, are needed to provide adequate assurances that hazards requiring a control in the food you import have been significantly minimized or prevented, as required by 21 CFR 1.506(d)(1)(i). Your FSVPs for Strawberry Syrup and Blueberry Syrup imported from your foreign supplier (b)(4), located in (b)(4) and your FSVP for your Canned Coconut Cream imported from your foreign supplier (b)(4), located in (b)(4), require that your suppliers provide certain information, including food safety audit information, as part of your supplier verification activities. However, none of these FSVPs indicate the frequency with which this verification activity must be conducted, as required by 21 CFR 1.506(d)(1)(i). Further, when we asked if you documented the frequency of your verification activities, you did not provide an answer or any further records of this verification activity. In addition, while you may rely on third-party food safety audits as part of your foreign supplier verification activities, you must ensure the audit considers applicable FDA food safety regulations, as required by 1.506(e)(1)(i)(B). For your foreign supplier (b)(4), located in (b)(4), which is your supplier for your Strawberry Syrup and Blueberry Syrup products, you provided an audit certificate performed by (b)(4). While the certificate states that your supplier met the requirements of “Global Standard for Food Safety Issue 6: July 2011”, there is no indication that the audit considered applicable FDA food safety regulations and information relevant to the foreign supplier’s compliance with those regulations. Additionally, there is no indication that you reviewed or assessed the results of this audit using a qualified individual, as required by 21 CFR 1.506(e)(1)(iii). You must also promptly review and assess the results of any third-party audit that constitutes a verification activity, document your review and assessment of the results of such activity, and take appropriate action if the results do not provide adequate assurances that the hazards requiring a control have been significantly minimized or prevented, as required by 21 CFR 1.506(e)(3). The field in your FSVP for your Strawberry Syrup and Blueberry Syrup products, imported from your foreign supplier (b)(4), located in (b)(4), which indicates whether such products have an applicable food safety audit or certification, was not completed. We note that the audit certificate for this supplier lists an expiry date of January 19, 2021. When our investigator inquired about the expired audit certificate, you informed them that this was the most updated third-party audit and that you did not have other documents of verification activities for these products.

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 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 (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 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: Nabeela J. Chaudhry, 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 Nabeela Chaudhry via email at [email protected]. Please reference CMS #652935 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