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WARNING LETTER

Nature’s Way Farms, LLC MARCS-CMS 641201 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
James B Martin
Recipient Title
Owner
Nature’s Way Farms, LLC

801 Bona Terra Drive
Suite 190
Pharr, TX 78577
United States

Issuing Office:
Division of Southwest Imports

United States


Dear Mr. Martin, 

On June 30 and July 11, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Nature’s Way Farms, LLC, located at 801 Bona Terra Drive, Suite 190, Pharr, TX 78577. We also conducted an inspection on October 21, 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 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 the foods from the foreign suppliers indicated in the attached list. Because of these significant violations, 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 to the FDA 483a, dated July 17, 2022, in which you stated that you have a consultant to develop your firm’s FSVP and you expect to have corrective actions by September 1, 2022. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your planned or completed corrective actions. To date, no additional FSVP documents beyond what you provided during the most recent inspection have been received by FDA.

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 the foods indicated in the attached list, including each of the following foods: 

• Fresh bell peppers imported from (b)(4) located in (b)(4) 
• Fresh avocados imported from (b)(4), located in (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 for which you appear to be in violation of section 805. We may place the foods 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)). 

Additionally, we offer the following comments:

You import fresh produce, which is “covered produce” as defined in 21 CFR 112.3. Your FSVP must demonstrate that your supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 419 of the FD&C Act (21 U.S.C. 350h) (regarding standards for produce safety) and the implementing regulations in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112). 

We also note that under 21 CFR 1.509(a), for each line entry of food product offered for importation into the United States, you must ensure that your name, electronic mail address (i.e., email), and unique facility identifier (UFI) recognized as acceptable by FDA, identifying you as the importer of the food, are provided electronically when filing entry with U.S. Customs and Border Protection. As the owner or consignee of food that is being offered for import into the United States, you are the importer (see 21 CFR 1.500).  The Data Universal Numbering System (DUNS) number is the UFI that is recognized as acceptable by FDA. DUNS numbers are assigned and managed by Dun & Bradstreet.  For your shipments of fresh bell peppers imported in entry HP7-0443728-1/41/1, fresh Persian cucumbers imported in entry HP7-0443470-0/21/1, and fresh avocados imported in entry HP7-0441435-5/11/1, you provided a DUNS number corresponding to your firm’s previous address and the email address associated with a third party. It is your responsibility to ensure that the required information under 21 CFR 1.509(a) is provided at the time of entry.

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 # 641201 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

Cc: 
Nature’s Way Farms, LLC 
801 Bona Terra Drive, Suite 190
Pharr, TX  78577

 
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