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  5. El Molino Bakery Supplies Inc - 593693 - 12/16/2019
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El Molino Bakery Supplies Inc MARCS-CMS 593693 —

Delivery Method:
Via Express Delivery
Food & Beverages

Recipient Name
Diana Ortegon
Recipient Title
General Manager
El Molino Bakery Supplies Inc

2875 N Berkley Lake Rd NW Ste 19
Duluth, GA 30096-4344
United States

Issuing Office:
Division of Southeast Imports

United States

December 16, 2019


Re: CMS # 593693

Dear Ms. Diana Ortegon:

On September 12, 2019, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at 2875 N Berkeley Lake Rd NW Ste 19, Duluth, GA 30096-4344. We also conducted an inspection on July 10, 2018. 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 https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361902.htm

During our September 12, 2019 inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the products that you import from your foreign supplier. Your firm did not have FSVPs for the products that 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, and the follow-up inspection on September 12, 2019, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.

We have not received your response to the Form FDA 483a.

Your significant violations of the FSVP regulation are as follows: Your firm did not have FSVPs for the products that you import. This was the case during the September 12, 2019 inspection, as well as the July 10, 2018 inspection. Some of the products for which you did not have an FSVP include Multi-color sprinkles, Strawberry filling, and Bavarian cream manufactured by (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.

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 Multi-color sprinkles, Strawberry filling, and Bavarian cream manufactured by (b)(4). We may place these foods 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: Maria Jiron, Compliance Officer, Division of Southeast Imports by either email at Maria.Jiron@fda.hhs.gov or 15100 NW 67th Ave. Suite 400, Miami Lakes, FL 33014 If you have any questions regarding this letter, you may contact Maria Jiron via email at Maria.Jiron@fda.hhs.gov. Please reference CMS # 593693 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.


Ruth P. Dixon
Program District Director
Division of Southeast Imports

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