Willis Ocean Inc.

WARNING LETTER Willis Ocean Inc. MARCS-CMS 606827 — April 30, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA EMAIL AND UNITED PARCEL SERVICE Product: Food & Beverages Recipient: Recipient Name William Cheng Recipient Title Owner Willis Ocean Inc. 968-970 Meeker Ave Brooklyn , NY 11222-3816 United States Issuing Office: Division of Northeast Imports United States WARNING LETTER CMS # 606827 April 30, 2020 Dear Mr. Cheng: On March 5, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at Willis Ocean Inc. 968-970 Meeker Ave, Brooklyn, NY 11222-3816. We also conducted an initial inspection on December 13 and 21 of 2017. 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 Frozen Vegetarian Food imported (b)(4) Spicy Beef Flavor Paste imported (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 March 5, 2020 and the initial FSVP inspection on December 21, 2017, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations. We acknowledge receipt of your email response to the December 21, 2017 Form FDA 483a, FSVP Observations dated July 12, 2018 wherein you state you have decided to terminate importing the Spicy Beef Flavor Paste product from your foreign supplier (b)(4) . We have not received your response to the Form FDA 483a that was issued to your firm during the follow-up inspection on March 5, 2020. 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 an FSVP for each of the following foods: • Frozen Vegetarian Food (b)(4) • Chinese Noodle (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 Frozen Vegetarian Food (b)(4) ; Chinese Noodle (b)(4) Spicy Beef Flavor Paste from your (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 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: 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 # 606827 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 Content current as of: 05/12/2020 Regulated Product(s) Food & Beverages