WARNING LETTER
Rich River Produce, LLC
MARCS-CMS 637401 —
October 04, 2022
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Ms. Karina D. Duarte
Recipient Title
President
Rich River Produce, LLC
P.O. Box 4121
Rio Rico
,
AZ
85648
United States
Issuing Office:
Division of Southwest Imports
United States
October 4, 2022
WARNING LETTER
Re: CMS #637401
Dear Ms. Karina D. Duarte:
On May 24, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Rich River Produce, LLC located at 32 Kipper Street, Suite B, Rio Rico, AZ 85648-6236. We also conducted an inspection on November 19, 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 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 have not received your response to the FDA 483a issued on May 24, 2022.
Your significant violations of the FSVP regulation are as follows:
1. 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 stated you did not develop an FSVP for any foods that you import, including:
Fresh serrano peppers imported from
(b)(4)
;
Fresh bell peppers imported from
(b)(4)
and;
Fresh jalapeno peppers imported
(b)(4)
.
You import fresh produce that is “covered produce” as defined in 21 CFR 112.3. As an importer of covered produce, you must have an FSVP that demonstrates 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).
During the inspection you provided our investigator with third-party audit certificates that you said were provided to you by your foreign suppliers for the foods listed above. However, the documents that are relevant to an FSVP are incomplete, and you did not provide a record of your review of the relevant documents or explain how they would apply to your FSVP program. Thus, these documents do not constitute an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a).
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 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)).
Additionally, we offer the following comments:
We note that under 21 CFR 1.509(a), for each line entry of food product offered for importation into the United States, you must provide your name, electronic mail (i.e., email) address, and unique facility identifier (UFI) recognized as acceptable by FDA, identifying you as the importer of the food, electronically when filing entry with U.S. Customs and Border Protection. 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. You did not provide your name or email address for your shipments of fresh serrano peppers and fresh bell peppers in entry number
(b)(4)
and fresh jalapeno peppers in entry
(b)(4)
, nor did you provide your DUNS number for entry number
(b)(4)
.
On April 27, 2022, FDA issued an updated guidance to replace the temporary policy put in place in March 2018, by stating that beginning on July 24, 2022, the use of the entity identification code “UNK” will no longer be an option when filing an entry with U.S. Customs and Border Protection. Beginning July 24, 2022, the temporary policy that provided for the use of “UNK” will no longer be in place. FSVP importers will be required to ensure that they are in compliance with the FSVP regulation by providing their valid 9-digit DUNS number in the Entity Number field. It is your responsibility to ensure that the required information under 21 CFR 1.509(a), including a valid DUNS number, is provided at the time of entry. You can find the Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers Regulation at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-compliance-providing-acceptable-unique-facility-identifier-foreign-supplier
.
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 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: CDR Toby H. Hill, Compliance Officer, Division of Southwest Imports, One Main Place, 1201 Main Street, Suite 7200, Dallas, TX 75202. If you have any questions regarding this letter, you may contact Compliance Officer CDR Toby H. Hill via email at toby.hill@fda.hhs.gov. Please reference CMS # 637401 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/
Stacy M. Below, Acting Director
Division of Southwest Imports
One Main Place
1201 Main Street, Suite 7200
Dallas, TX 75202
Content current as of:
02/28/2023
Regulated Product(s)
Food & Beverages