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WARNING LETTER

Prime Line Distributors, Inc. MARCS-CMS 605669 —


Delivery Method:
Via Express Delivery
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Dennis Landi
Recipient Title
Vice President
Prime Line Distributors, Inc.

2800 SW 42nd Street
Ft. Lauderdale, FL 33312
United States

Issuing Office:
Division of Southeast Imports

United States


WARNING LETTER

April 9, 2020

Re: CMS # 605699

Dear Mr. Landi:

On February 12, 2020, the U.S. Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at Prime Line Distributors Inc., located at 2800 SW 42nd St. Ft. Lauderdale FL 33312. We also conducted an inspection on August 28, 2017. 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 your FSVPs for food products you import including, but not limited to, hazelnut paste, Gran Padano cheese, and Parmigiano Reggiano cheese from your foreign suppliers. 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 the FSVP inspection, and the follow-up inspection on February 12, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.

We acknowledge receipt of your response dated February 26, 2020, where you included a one-page letter with an attachment. In your letter, you stated that you are working with a consulting company to develop your FSVP plan(s) in the next 60 days and that you obtained a letter of guarantee from (b)(4) for the hazelnut paste stating that they would comply with the FD&C Act. We are unable to evaluate the adequacy of your statement because you did not provide details as to what FSVP requirements your program will include or what products will be covered. You stated that you no longer import Gran Padano Cheese or Parmigiano Reggiano Cheese from (b)(4), and thus do not have an FSVP. Based on our review of your current shipping history, you imported Gran Padano on March 1, 2020, and Parmigiano Reggiano cheese on March 19, 2020, from other suppliers in Italy.

Your significant deviation is described below:

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 FSVPs for each of the following foods:
• Hazelnut Paste imported from (b)(4)
• Gran Padano Cheese and Parmigiano Reggiano Cheese 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.

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 Hazelnut Paste imported from (b)(4) and Gran Padano Cheese and Parmigiano Reggiano Cheese imported from (b)(4). We may place the food from the identified 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 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: Carlos W. Hernandez, Compliance Officer, Division of Southeast Imports, 15100 NW 67th Ave. Suite 400, Miami, FL 33014. If you have any questions regarding this letter, you may contact Officer Hernandez via email at carlos.hernandez@fda.hhs.gov. Please reference CMS # 605699 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 P. Dixon
Program Division Director
Division of Southeast Imports

 
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