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WARNING LETTER

Kaymile Trading, Inc. MARCS-CMS 608153 —


Delivery Method:
United Parcel Service
Product:
Food & Beverages

Recipient:
Recipient Name
Nancy H. Zhang
Recipient Title
CEO
Kaymile Trading, Inc.

2615 Loma Avenue
South El Monte, CA 91733-1419
United States

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

United States


WARNING LETTER

July 28, 2020

Re: CMS # 608153

Dear Ms. Zhang:

On April 24, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection at Kaymile Trading, Inc., 2615 Loma Avenue, South El Monte, California 91733-1419. We also conducted an initial on-site FSVP inspection on September 6, 2018. 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 your roasted onion granules imported from (b)(4) and coarse black pepper imported from (b)(4), and roasted garlic granules imported from (b)(4). You did not have FSVPs for the roasted onion granules or coarse black pepper products.

While you provided a Hazard Analysis and Critical Control Point (HACCP) plan document for the roasted garlic granules, you did not meet the FSVP requirements for this product, as discussed in greater detail below. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of both the initial FSVP inspection on September 6, 2018, and the follow-up inspection on April 24, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations. We have not received your response to either Form FDA 483a.

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, your firm did not develop an FSVP for each of the following foods:
a. Roasted onion granules imported from (b)(4) located in (b)(4).
b. Coarse black pepper imported from (b)(4) located in (b)(4).

2. For the roasted garlic granules imported from (b)(4), located in (b)(4), you did not meet your requirements to conduct a hazard analysis in accordance with 21 CFR 1.504(a). During the inspection, you provided a copy of your foreign supplier’s HACCP plan. You may meet your requirement to conduct a hazard analysis, as required by 21 CFR 1.504(a), by reviewing and assessing your supplier’s hazard analysis and documenting your review and assessment of your supplier’s hazard analysis per 21 CFR 1.504(d). You did not provide documentation that you have reviewed and assessed your foreign supplier’s hazard analysis as required by 21 CFR 1.504(d).

3. You must approve your foreign suppliers on the basis of an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505(a), and document your approval, as required by 21 CFR 1.505(b). You did not document your approval of your foreign supplier of roasted garlic granules imported from (b)(4), as required by 21 CFR 1.505(b).

4. You did not 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).

5. You did not establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the foods you import, as required by 21 CFR 1.506(b).

6. You did not conduct and document (or obtain documentation of) one or more of the supplier verification activities listed in 21 CFR 1.506(e)(1)(i) through (iv) for each foreign supplier before importing the food and periodically thereafter, as required by 21 CFR 1.506(e). For example, you did not conduct and document (or obtain documentation of) one or more of such supplier verification activities for your foreign supplier (b)(4), before importing roasted garlic granules and periodically thereafter.

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 these violations, 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 roasted onion granules from your foreign supplier (b)(4), and roasted garlic granules and coarse black pepper from your foreign supplier (b)(4).

We may place these foods from the identified foreign suppliers on detention without physical examination (DWPE) when you import these 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 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 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: James R. Ahlrep, Compliance Officer, Division of West Coast Imports, U.S. Food and Drug Administration, 19701 Fairchild, Irvine, California 92612-2506. If you have any questions regarding this letter, you may contact James Ahlrep via email at james.ahlrep@fda.hhs.gov. Please reference CMS #608153 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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