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WARNING LETTER

July 5, 2022

Re: CMS 634004

Dear Mr. Emrah Bayram:

On February 22, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Bolive, Inc. located at 755 N. Central Ave., Unit B, Upland, CA 91786. 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/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.

During the inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods you import from the foreign suppliers indicated in the attached list and for the (b)(4) halva and (b)(4) tahini you import from (b)(4), located in (b)(4), and the black olives you import from (b)(4), located in (b)(4). 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 March 15, 2022, sent by Mr. Daniel Hue of United Consulting Services (UCS) on your behalf, which included a letter of power of attorney authorizing Mr. Hue to represent you in the course of communicating with FDA on this matter, and we address your response below.

Your significant violations of the FSVP regulation are as follows:

1. You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, you did not develop an FSVP for the foods you import from the foreign suppliers indicated in the attached list and for:

• (b)(4) Halva and (b)(4) Tahini imported from foreign supplier (b)(4) in (b)(4)
• Black Olives imported from foreign supplier (b)(4) in (b)(4)

Your March 15, 2022 response, sent by Mr. Hue on your behalf, stated the following: you do not have a FSVP plan in place, your average annual sales of all imported food for the previous three years are (b)(4), and you wish to be subject to the modified FSVP requirements. Your response requested six weeks (i.e., until April 26, 2022) “to develop and deliver a FSVP food safety plan in entirety.” However, you did not provide supporting documentation that you meet the definition of a very small importer (see 21 CFR 1.500 for the definition of a very small importer). Moreover, to date, we still have not received any FSVP records from you. Even if you meet the definition of very small importer, you are still required to follow FSVP requirements. If you are a very small importer and you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of very small importer in 21 CFR 1.500 before initially importing food as a very small importer and thereafter on an annual basis by December 31 of each calendar year (21 CFR 1.512(b)(1)(i)(A)). If section 1.512 applies and you choose to comply with the requirements in section 1.512(b), you also are required to comply with the requirements in sections 1.502, 1.503, and 1.509, but you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510. In addition, for each food you import, you must obtain written assurance, before importing the food and at least every two years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) of the FD&C Act (21 CFR 1.512(b)(3)(i)).

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 from the identified foreign suppliers 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 working 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: CDR Ellen Yip, Compliance Officer, Division of West Coast Imports, 19701 Fairchild Road, Irvine, California, 92612. If you have any questions regarding this letter, you may contact CDR Ellen Yip via email at [email protected]. Please reference CMS # 634004 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/

For Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports

cc:

Mr. Daniel Hue
Attorney, United Consulting Services