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  5. Meditco, Inc. D.B.A. Phoenicia Specialty Foods - 673485 - 02/27/2024
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WARNING LETTER

Meditco, Inc. D.B.A. Phoenicia Specialty Foods MARCS-CMS 673485 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Raffi Tcholakian
Recipient Title
Operations Manager
Meditco, Inc. D.B.A. Phoenicia Specialty Foods

12141 Westheimer Rd.
Houston, TX 77077
United States

Issuing Office:
Division of Southwest Imports

One Main Place
1201 Main Street, Suite 7200
Dallas, TX 75202
United States

February 27, 2024


WARNING LETTER

 

Re:  CMS # 673485

Dear Mr. Raffi Tcholakian:

On November 8 to November 15, 2023, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of Meditco, Inc. D.B.A. Phoenicia Specialty Foods located at 12141 Westheimer Rd., Houston, TX 77077. We also conducted inspections on June 29 to July 7, 2020, April 4 to April 12, 2022, and October 19 to 25, 2022. 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 response dated December 6, 2023, in which you stated you are hiring (b)(4) to develop an FSVP for all products your firm imports. You also stated that you estimate to have a fully developed FSVP and corresponding records ready within the next 6 – 8 months, similar to statements you made in your responses to previous inspections. We are unable to evaluate the adequacy of your response because you have not provided supporting documentation demonstrating your planned or completed corrective actions.

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 an FSVP for any of the foods you import, including the following foods:

•    (b)(4) Chickpeas imported from (b)(4) located in (b)(4)
•    Falafel Spices imported from (b)(4) located in (b)(4)
•    Rose Syrup imported from (b)(4) located in (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)).

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 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 Emmanuel Dominguez via email at Emmanuel.Dominguez@fda.hhs.gov. Please reference CMS # 673485 on any documents or records you provide to us and within the subject line of any email correspondence you send to us.
 
Sincerely,
/S/
Alexander Lopez
Acting Director, Southwest Imports
One Main Place
1201 Main Street, Suite 7200
Dallas, TX 75202

 
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