WARNING LETTER
La Parcela Produce LLC
MARCS-CMS 682277 —
July 16, 2024
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Jose Jesus Garcia Herrera
La Parcela Produce LLC
9231 Penn Ave. S., Suite 4
Bloomington
,
MN
55431-2302
United States
Issuing Office:
Division of Northern Border Imports
United States
July 16, 2024
WARNING LETTER
Re: CMS # 682277
Dear Mr. Jose Jesus Garcia Herrera:
From February 28, 2024, through March 26, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of La Parcela Produce LLC located at 9231 Penn Ave. S, Suite 4, Bloomington, MN 55431-2302. 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/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 FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals | FDA
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 acknowledge receipt of your response dated April 14, 2024. Your response indicates you have “denied” and sent letters terminating your commercial relationship with foreign suppliers
(b)(4)
and
(b)(4)
. Your response stated these suppliers were denied because they did not provide verification activities per your request and they are on an import alert. We will verify the adequacy of your corrective activities during a future inspection. Your response also provided a document titled, “FOREIGN SUPPLIER VERIFICATION PROGRAM” for your cilantro, lettuce, and poblano pepper imported from your foreign supplier,
(b)(4)
. The FSVP documents are marked as “pending” and include a hazard analysis for each of the foods. We address your response below.
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 did not develop an FSVP for the foods you import from the foreign suppliers indicated in the attached list, except for the following foods:
Cilantro, lettuce, and poblano pepper imported from
(b)(4)
, Mexico
Your response dated April 14, 2024 did not provide corrective actions for the foods you import from the foreign suppliers between 01/01/2023 – 02/29/2024 indicated in the list, as described above, except for
(b)(4)
and
(b)(4)
, which you have indicated that you have denied.
2) You did not meet the requirement to conduct and document (or obtain documentation of) one or more of the supplier verification activities listed in 21 CFR 1.506(e)(1)(i) through (iv) for each foreign supplier before importing the food and periodically thereafter, as required by 21 CFR 1.506(e). Specifically, you did not conduct and document (or obtain documentation of) one or more such supplier verification activities for your foreign supplier,
(b)(4)
before importing cilantro, lettuce, and poblano pepper, and periodically thereafter. During the inspection you were unable to provide the documentation. Your written response dated April 14, 2024 did not provide the documentation.
You import cilantro, lettuce, poblano pepper, and jalapeno, which are “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).
3) You did not establish and follow written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import as required by 21 CFR 1.506(b). Specifically, you did not establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted for the foods you import, including cilantro, lettuce, and poblano pepper that you imported from
(b)(4)
, located in Mexico. During the inspection you were unable to provide the documentation. Your written response dated April 14, 2024 did not provide the documentation.
4) You did not meet the requirement to, before importing a food from a foreign supplier, determine and document which verification activity or activities, as well as the frequency with which the activity or activities must be conducted, are needed to provide adequate assurances that the food you obtain from the foreign supplier is produced in accordance with 21 CFR 1.506(c), as required by 21 CFR 1.506(d). For example, your FSVP for cilantro, lettuce, and poblano pepper imported from your foreign supplier,
(b)(4)
, located in Mexico, does not document which verification activity or activities listed in 1.506(d)(1)(ii)(A) through (D), as well as the frequency with which the activity or activities must be conducted, are needed to provide adequate assurances that the food you obtain from the foreign supplier is produced in accordance with 21 CFR 1.506(c), as required by 21 CFR 1.506(d). During the inspection, your wholesale representative stated she would start creating FSVPs for the foreign suppliers who have the verification activity of onsite audit and those who did not have an onsite audit would not be utilized as foreign suppliers until they were in compliance with your firm’s Foreign Supplier Verification Program. Your written response dated April 14, 2024 did not provide documentation of verification activities.
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 State of an article of food without the importer having 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 any violations. You should include in your response documentation and information that would assist us in evaluating your correction (e.g., documents 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 you delay and state when you will correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: Rachele A. Saisselin, Compliance Officer, Division of Northern Border Imports. If you have any questions regarding this letter, you may contact Compliance Officer Saisselin via email at Rachele.Saisselin@fda.hhs.gov. Please reference CMS #682277 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Sincerely,
/S/
Keith J. Jasukaitis
Program Division Director
Division of Northern Border Imports
Content current as of:
08/06/2024
Regulated Product(s)
Food & Beverages