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WARNING LETTER

Babylon, Inc. MARCS-CMS 610009 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Johny H. Mushi
Recipient Title
President
Babylon, Inc.

8033 N. Oketo Ave.
Niles, IL 60714
United States

Issuing Office:
Division of Northern Border Imports

United States

September 3, 2020

WARNING LETTER

Re: CMS # 610009

Dear Mr. Johny H. Mushi:

On May 7-8, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection for Babylon Inc. located at 8033 N. Oketo Ave., Niles, IL 60714. 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 Foreign Supplier Verification Program (FSVP) implementing 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 inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your tahini imported from (b)(4) and (b)(4), located in (b)(4), and (b)(4), located in (b)(4). You did not have an FSVP for these products or any food products that you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. This inspection was initiated based on isolation of Salmonella, from a sample of tahini manufactured by (b)(4). The sample was collected from entry (b)(4), imported by your company.

At the conclusion of the FSVP inspection, our investigator provided you with Form FDA 483a, FSVP Observations.

We acknowledge you voluntarily destroyed all tahini manufactured by (b)(4) on the entry referenced above, under Customs Border Protection (CBP) supervision on April 30, 2020. However, to date, we have not received your response to the Form FDA 483a for your FSVP violations and the voluntarily destructions do not address the FSVP violations.

Your significant violation of the FSVP regulation is 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, your firm did not develop an FSVP for each of the following foods:
• Tahini manufactured by (b)(4);
• Tahini manufactured by (b)(4); and
• Tahini 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 the food products you import. We may place the foods you import on detention without physical examination (DWPE) when you import the products. You can find DWPE information relating to FSVP in Import Alert # 99-19, at https://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.

In addition, (b)(4) brand tahini is currently subject to DWPE per import alert 99-19, as a consequence of being found contaminated with Salmonella. You can find DWPE information relating to Import Alerts at https://www.accessdata.fda.gov/cms_ia/ialist.html.

Additionally, we offer the following comment:

We note that, based on (b)(4), you may (b)(4), 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 as required per 21 CFR 1.512(b)(1)(i). If this section applies and you choose to comply with the requirements in paragraph (b) of this section, 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) (if applicable) of the FD&C Act (21 CFR 1.512(b)(3)(i)).

Please email your reply to Food and Drug Administration, Attention: Erica Koory, Compliance Officer, Division of Northern Border Imports, at erica.koory@fda.hhs.gov. Please reference CMS # 610009 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/

Keith J. Jasukaitis
Program Division Director
Division of Northern Border Imports

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