Fresh Imports International LLC

WARNING LETTER Fresh Imports International LLC MARCS-CMS 627330 — May 04, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Express Delivery Product: Food & Beverages Recipient: Recipient Name Robert L. Diaz Recipient Title Owner Fresh Imports International LLC PO Box 8118 Hidalgo , TX 78557 United States Issuing Office: Division of Southwest Imports United States May 4, 2022 Re: CMS # 627330 Dear Mr. Diaz, On January 31 through February 2, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Fresh Imports International LLC, located at 711 E Produce Rd. Hidalgo, TX 78557. We also conducted an inspection on August 18, 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 Foreign Supplier Verification Program (FSVP) implementing 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 you import, including fresh avocados from (b)(4) , fresh pineapples from (b)(4) , and fresh avocados from (b)(4) . Because of this significant violation, you are not in compliance with section 805 of the FD&C Act. At the conclusion of the most recent inspection, our investigator provided you with Form FDA 483a, FSVP Observations. We acknowledge receipt of your response, dated February 2, 2022, in which you stated that you did not “have what is required in place,” but you have a plan to “follow FDA guidelines for FSVP.” You also stated you will sign up to take a FSVP class. However, we note that this is the second inspection in which you did not have any FSVP records, and you did not provide any documentation of the activities that you are taking in order to comply. Your significant violation 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 part 1.502(a). Specifically, your firm did not develop an FSVP for any of the foods you import, including each of the following: Fresh avocados imported from (b)(4) Fresh pineapples imported from (b)(4) Fresh avocados imported from (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. 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 which appear to be in violation of section 805. We may place these foods you import into the United States on detention without physical examination (DWPE) when you import the foods. 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)). We also note that, since you import fresh produce, which is “covered produce” as defined in 21 CFR 112.3, your FSVP must demonstrate your supplier is in compliance with the requirements in the Produce Safety Rule (21 CFR Part 112). 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 working days, you should explain the reason for your delay and state when you will correct any remaining violations. Please send your reply to the Food and Drug Administration, Attention: Zumera Ajani, Compliance Officer, Division of Southwest Imports, 1201 Main Street, Suite 7200, Dallas, TX 75202. If you have any questions regarding this any letter, you may contact Compliance Officer Zumera Ajani via email at Zumera.Ajani@fda.hhs.gov. Please reference CMS # 627330 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/ Todd Cato Program Division Director Division of Southwest Imports 1201 Main Street, Suite 7200 Dallas, TX 75202 Content current as of: 06/28/2022 Regulated Product(s) Food & Beverages