Fides Ny Inc

WARNING LETTER Fides Ny Inc MARCS-CMS 608989 — July 29, 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 Tae Shin Recipient Title Owner Fides Ny Inc 4725 208th Street Bayside , NY 11361-3208 United States Issuing Office: Division of Northeast Imports United States WARNING LETTER CMS # 608989 Dear Mr. Tae Shin: On May 26, 2020 and May 28, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Fides New York Inc. located at 4725 208th Street, Bayside, NY 11361-3214. We also conducted an initial on-site FSVP inspection on June 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 were not in compliance with the requirements of 21 CFR part 1 subpart L for the food products you import including, but not limited to, Namja Ramen imported from your foreign supplier (b)(4) ; Aloe Drink imported from your foreign supplier (b)(4) ; and Frozen Yogurt Drink Green Apple Flavor imported from your foreign supplier (b)(4) . Your firm did not have FSVPs for these products or for any products that you import. 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 May 28, 2020 and the initial FSVP inspection on June 6, 2018, 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: 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 the products that you import including: o Namja Ramen imported from your foreign supplier, (b)(4) o Aloe Drink imported from your foreign supplier, (b)(4) o Frozen Yogurt Drink Green Apple Flavor 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 the food products you import. We may place the foods you import 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: Teresa T. Cain, FDA Compliance Officer, Division of Northeast Imports, by email to ORAOEIONEIMPORTSWLResponses@fda.hhs.gov . Please also cc (carbon copy) teresa.cain@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Cain via email at teresa.cain@fda.hhs.gov. Please reference CMS # 608989 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: 08/25/2020 Regulated Product(s) Food & Beverages