---

---

---

March 2, 2022

WARNING LETTER

Re: CMS # 624666

Dear James Cass Keeler:

On November 16, 2021, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of Keeler Family Farms located at 230 Sunshine Rd Se, Deming, NM. This inspection was 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 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.

The inspection was initiated due to an investigation of a multistate foodborne outbreak of Salmonella Oranienburg illnesses linked to whole, fresh onions imported from the State of Chihuahua, Mexico. We acknowledge you initiated a voluntary recall on October 22, 2021, of red, yellow, and white onions imported by your company from your suppliers (b)(4) in Chihuahua, Mexico between July 1, 2021 through August 25, 2021.

During the inspection, we found that you were not in compliance with the requirements of 21 CFR part 1 subpart L for any of the foods you import, including your whole, fresh onions imported from (b)(4), who are all located in Chihuahua, Mexico. Your firm did not have FSVPs for these foods or for any of the foods you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations. We received your response to the Form FDA 483a on December 14, 2021. In your response, you stated that “if this company moves forward we will ensure that an FSVP program and all grower certifications will be effective by June 15, 2022.” We acknowledge that during the inspection, you informed our investigator that you would begin researching the FSVP requirements and would consider taking FSVP training to assist in developing FSVP records for all foreign suppliers. Furthermore, you stated that you would only use “Keeler Family Farms” as the FSVP importer (FSVPI). Our records show that you continue to import covered foods, including alfalfa hay and fresh hot peppers, into the United States under various FSVPIs. To be in compliance with section 805 of the FD&C Act, you must develop an FSVP for each of the foods you import before importation of covered foods into the U.S.

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, you did not develop an FSVP for any foods you import, including whole, fresh onions imported from your foreign suppliers, (b)(4), located in Chihuahua, Mexico.

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 for which you appear to be in violation of section 805. We may place the foods you import from the identified foreign suppliers 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)).

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 will 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 the foods you import 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: Melissa G. Gonzalez, Compliance Officer, the Division of Southwest Imports, 216 West Village Blvd, Suite 107, Laredo, Texas 78041. If you have any questions regarding this letter, you may contact Melissa G. Gonzalez via email at melissag.gonzalez@fda.hhs.gov. Please reference CMS # 624666 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
Division Director
Division of Southwest Imports