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WARNING LETTER

H & C Food Inc. MARCS-CMS 607742 —


Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Food & Beverages

Recipient:
Recipient Name
Sai Lu Pan
Recipient Title
Owner & CEO
H & C Food Inc.

1300 Metropolitan Ave.
Brooklyn, NY 11237
United States

Issuing Office:
Division of Northeast Imports

United States


WARNING LETTER
CMS # 607742


Dear Ms. Sai Lu Pan:

On April 9, 2020 and April 14, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of H & C Food Inc., located at 1300 Metropolitan Ave, Brooklyn, NY 11237. We also conducted an initial on-site FSVP inspection on August 23, 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 Enoki Mushroom imported from Green Co., Ltd, South Korea and Teriyaki Kimnori Roasted seaweed Snack (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 both the most recent inspection on April 14, 2020 and the initial FSVP inspection on August 23, 2018, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.

We acknowledge receipt of your two emailed responses on May 4, 2020, one of which included attachments you describe as being from your “Korean fresh enoki mushroom supplier” and the other from your “Roasted Seaweed supplier (b)(4).” The four documents you associated with your Enoki Mushroom supplier are a Hazard Analysis Critical Control Point (HACCP) plan not translated to English, a Processing Risk Assessment that does not reference a product or company, and a Corrective Action plan and Staff Safety Risk Assessment that both list (b)(4), Green Co. Ltd.). The two documents you associated with your Teriyaki Kimnori Roasted seaweed Snack supplier are a HACCP plan for roasted products and copies of nutritional labeling for seasoned seaweed. 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 for these products. We also received your email on April 29, 2020, where you provided attachments related to your frozen rice balls and pears imported from (b)(4), which were not covered during our inspection.

Your significant violations of the FSVP regulation are as follows:

You did not meet your requirements to conduct a hazard analysis for your Enoki Mushroom imported from Green Co., Ltd., located in South Korea and your Teriyaki Kimnori Roasted seaweed Snack imported from (b)(4) in accordance with 21 CFR 1.504 because you did not evaluate your foreign suppliers’ performance in accordance with 21 CFR 1.505, nor did you perform foreign supplier verification activities in accordance with 21 CFR 1.506. Specifically, you did not document your review and assessment of your foreign supplier’s hazard analysis as required by 21 CFR 1.504(d). The FSVP regulation also generally requires that you evaluate your foreign supplier’s performance (21 CFR 1.505) and conduct foreign supplier verification activities (21 CFR 1.506), among other requirements.

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 the Enoki Mushroom imported from Green Co. Ltd., South Korea, and Teriyaki Kimnori Roasted seaweed Snack imported (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). Please provide an English translation of any records that you provide in a language other than English in order to facilitate our review. 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: David A Trent-Carlson, FDA Compliance Officer; Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) david.trent-carlson@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Trent-Carlson via email at david.trent-carlson@fda.hhs.gov. Please reference CMS # 607742 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/

Dawne Hines
Program Division Director
Division of Northeast Imports

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