- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMr. Hugo Martinez
- Martinez Mexican Produce LLC
1704 N. International Blvd
Hidalgo, TX 78557
- Issuing Office:
- Division of Southwest Imports
June 16, 2020
Re: CMS # 607645
Dear Mr. Martinez:
On March 6, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of Martinez Mexican Produce, LLC, at 1704 N. International Blvd., Hidalgo, TX 78557. We also conducted an inspection on February 15, 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-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 mayonnaise imported from (b)(4) and shredded coconut imported from (b)(4). Your firm did not have FSVPs for these products. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of both the most recent inspection on March 6, 2020 and the initial FSVP inspection on February 15, 2018, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
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, your firm did not develop an FSVP for each of the following foods:
• Mayonnaise manufactured by (b)(4) (e.g., entry# BYX-0135279-2 Line 11/1)
• Shredded coconut manufactured by (b)(4) (e.g., entry# BYX-0141144-0 Line 101/1)
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.
You should take prompt action to correct the above violations. If you do not promptly correct them, 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 mayonnaise manufactured by (b)(4) and shredded coconut manufactured by (b)(4). We may place all foods from your foreign suppliers 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 these 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 revised 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 your products 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 Food and Drug Administration, Attention: Emmanuel Dominguez, Compliance Officer, Division of Southwest Imports, 216 W. Village Blvd., Suite 107, Laredo, TX 78041 . If you have any questions regarding this letter, you may contact Mr. Emmanuel Dominguez via email at Emmanuel.Dominguez@fda.hhs.gov. Please reference CMS # 607645 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.
Division of Southwest Imports
4040 North Central Expressway
Dallas, TX 75204