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WARNING LETTER

Export Guatemala Corporation MARCS-CMS 632380 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Nescho Fernando Pablo Felipe
Recipient Title
Vice President
Export Guatemala Corporation

318 N Dixie Hwy
Lake Worth, FL 33460-3364
United States

Issuing Office:
Division of Southeast Imports

United States

May 31, 2022

WARNING LETTER

Re: CMS # 632380

Dear Mr. Felipe:

On February 17, 2022, the U.S. Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Export Guatemala Corporation, located at 318 N Dixie Hwy, Lake Worth, FL 33460-3364. We also conducted an inspection on November 19 - 20, 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 acknowledge receipt of your emailed response dated March 02, 2022, to the Form FDA 483a. In your email you state that you sent a letter to your suppliers in Guatemala, requesting information “to comply with FSVP records” but that there was a lack of response. You further state you will send a representative to visit your suppliers to obtain the information you need to comply with the FSVP requirements and ask for an additional 6 months to obtain the records. You did not include any documents or additional details regarding the information you seek to obtain as it relates to the FSVP requirements. Further, aside from stating you are seeking information from your suppliers, you have not provided specific steps or actions you have taken or plan to take to come into compliance with the FSVP regulation. Our review of your response finds that you have not addressed the violations related to the food products you import. Specifically, you have not made any corrections or developed FSVPs for the foods you import since our initial inspection in November 2020.

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 FSVPs for any of the foods you import, including:

  • Cacao Paste, imported from (b)(4).
  • Corn Chips, imported from (b)(4).
  • Whole White Corn, 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.

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)).

We also have the following comments:

Additionally, we note that you may meet the definition of a “very small importer” under 21 CFR 1.500. If you meet the definition, you are still required to follow FSVP requirements. If you are a very small importer and you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of very small importer as required per 21 CFR 1.512(b)(1)(i). If this section applies and you choose to comply with the requirements in paragraph (b) of this section, you are required to comply with the requirements in sections 1.502, 1.503, and 1.509. However, you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510. In addition, for each food you import, you must obtain written assurance, before importing the food and at least every 2 years thereafter, that your foreign 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 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) of the FD&C Act (21 CFR 1.512(b)(3)(i)).

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., 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 Food and Drug Administration, Attention: Jason Ferry, Compliance Officer, Division of Southeast Imports, 959 Ridgeway Loop Road, Ste. 100, Memphis, TN 38120. If you have any questions regarding this letter, you may contact Officer Ferry via email at jason.ferry@fda.hhs.gov. Please reference CMS case # 632380 and work activity # 442832 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/

Ruth Dixon
Program Division Director
Division of Southeast Imports

 
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