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  5. Jaramillo Spices Corp. - 614760 - 06/08/2021
  1. Warning Letters

WARNING LETTER

Jaramillo Spices Corp. MARCS-CMS 614760 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Victor (NMI) Jaramillo Sr.
Recipient Title
Manager and Owner
Jaramillo Spices Corp.

2501 W Military Hwy. Ste. D5 & D6
McAllen, TX 78503-8963
United States

Issuing Office:
Division of Southwest Imports

United States

June 8, 2021

Re: CMS # 614760

Dear Mr. Jaramillo Sr.:

From March 26 through April 9, 2021 the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Jaramillo Spices Corp located at 2501 W Military Hwy. Ste. D5 & D6, McAllen, TX. We also conducted an inspection on November 14, 2018. 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-safetymodernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humansand-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 food products that you import, including but not limited to, fresh tamarind imported from your foreign supplier (b)(4); dried black beans imported from your foreign supplier (b)(4); and vanilla flavoring imported from your foreign supplier (b)(4). You did not have FSVPs for these products or any of the food products you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of both the initial FSVP inspection on November 14, 2018 and the follow-up inspection on April 9, 2021, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations. As of the date of this letter, we have not received your response to either Form FDA 483a.

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, maintain, and follow an FSVP for any of the food products you import, including the following foods:

  • Fresh tamarind imported from (b)(4)
  • Black beans imported from (b)(4)
  • Vanilla flavoring 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.

(b)(3)(A)

As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.

(b)(3)(A)

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in 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 products you import for which you appear to be in violation of section 805. We may place the foods you import on detention without physical examination (DWPE) when you import the products. 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.

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 using the Division Address at the top of the page. 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 # 614760 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 of Southwest Imports Director
One Main Place
1201 Main Street, Suite 7200
Dallas, TX 75202

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