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  5. Copoliva Inc. - 606681 - 06/16/2020
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WARNING LETTER

Copoliva Inc. MARCS-CMS 606681 —

Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. James Deeb
Recipient Title
CEO
Copoliva Inc.

7923 Gloria Ave.
Van Nuys, CA 91406-8383
United States

Issuing Office:
Division of West Coast Imports

United States

WARNING LETTER

June 16, 2020

Re: CMS # 606681

Dear Mr. Deeb:

On March 18, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at Copoliva, Inc., 7923 Gloria Avenue, Van Nuys, CA 96406. We also conducted an inspection on September 13, 2018. These inspections were conducted to determine your 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 our most recent inspection, we found that you were not in compliance with the requirements of 21 CFR part 1 subpart L for your Refined Rice Bran Oil that you import from your foreign supplier (b)(4)., located in (b)(4); your Grape Seed Oil, that you import from your foreign supplier (b)(4), located in (b)(4); and your Organic High Oleic Sunflower Oil that you import from your foreign supplier (b)(4), located in the (b)(4). You did not have FSVPs for these products, or any food product which your firm imports. 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 March 18, 2020, 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:

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 each of the following foods:

• Refined Rice Bran Oil, manufactured by (b)(4)., located in (b)(4)
• Grape Seed Oil, manufactured by (b)(4), located in (b)(4)
• Organic High Oleic Sunflower Oil, manufactured by (b)(4), located in the (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 (21U.S.C. 381(a)(3)) to refuse admission of Refined Rice Bran Oil products imported from your foreign supplier (b)(4); Grape Seed Oil products imported from your foreign supplier (b)(4); and Organic High Oleic Sunflower Oil products imported from your foreign supplier (b)(4), the (b)(4). We may place these foods from the identified foreign suppliers on detention without physical examination (DWPE) when you import these 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 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: David Serrano, Compliance Officer, Division of West Coast Imports, 1 World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Mr. Serrano via email at david.serrano@fda.hhs.gov. Please reference CMS # 606681 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/

Dan Solis
Program Director
Division of West Coast Imports

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