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  5. Apollo Import Export, Inc. - 663674 - 09/26/2023
  1. Warning Letters

WARNING LETTER

Apollo Import Export, Inc. MARCS-CMS 663674 —

Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Samvel Oganesyan
Recipient Title
President
Apollo Import Export, Inc.

13340 Saticoy St., Ste. O
North Hollywood, CA 91605-7644
United States

Issuing Office:
Division of West Coast Imports

United States

WARNING LETTER

September 26, 2023

Re: CMS # 663674

Dear Mr. Oganesyan:

On May 02, 2023, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of your firm Apollo Import Export Inc., located at 13340 Saticoy St., Ste. O, North Hollywood, California 91605-7644. We also conducted an inspection on April 6, 2021 to April 16, 2021, and on June 28, 2022 to July 14, 2022. 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 have been produced in a manner that meets applicable U.S. food safety standards. You will 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 have not received your response to the Form FDA 483a issued on May 02, 2023.

Your significant violations of the FSVP regulations 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 1.502(a). Specifically, your firm did not develop an FSVP for any of the foods that you import, including:

  • Adjika (Red Pepper Tomato Dip), Hot Eggplant Spread (Caviar), and Imam Bayaldi (Eggplant Spread) imported from (b)(4);
  • Natakhtari (Pear) Soft Drink imported from (b)(4).

During our inspection, you provided the investigator with two documents you obtained from your foreign suppliers: a one-page letter from your foreign supplier (b)(4) with information regarding “prevention and control of biological, chemical and physical hazards during production of acidified canned food products,” with no specific product identified, and a letter from your foreign supplier (b)(4) listing their certificates from organizations (b)(4) for the production of beer and carbonated soft drinks. Although these documents could be relevant to development of an FSVP, you did not provide a record of your review of the documents or explain how they would apply to your FSVP program. Thus, these documents do not constitute an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a).

2. For thermally processed low-acid foods packaged in hermetically sealed containers (low-acid canned foods), with respect to those microbiological hazards that are controlled by following 21 CFR part 113, you must verify and document that they were produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1). However, you did not verify and document that your Adjika (Red Pepper Tomato Dip), Hot Eggplant Spread (Caviar), and Imam Bayaldi (Eggplant Spread) imported from (b)(4), which are all low-acid canned foods, were produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1).

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.

In addition, FDA has determined that your facility located at 13340 Saticoy St., Ste O, North Hollywood, CA 91605-7644 is subject to the food facility registration requirement in section 415 of the FD&C Act (21 U.S.C. 350d) and our implementing regulations at 21 CFR part 1, subpart H. Section 415(a)(3) of the Act requires facilities that are required to register with FDA to renew their registrations every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year. Our records indicate that your facility is not currently registered. Failure to register a facility as required is a prohibited act under section 301(dd) of the Act [21 U.S.C. 331(dd)].

As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.

We request that the owner, operator, or agent in charge of this facility, or an individual authorized by this facility’s owner, operator, or agent in charge, register the facility with FDA within 30 working days of the date of this letter. Food facility registration guidance is available online at https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions. Registration may be accomplished online at http://www.access.fda.gov. You must submit your registration or registration renewal to FDA electronically, unless FDA has granted you a waiver under 21 CFR 1.245 (21 CFR 1.231(a)(4)).

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in 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 food 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.

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 working days, you should explain the reason for your delay and state when you will correct any remaining violations.

Please send your reply to U.S Food and Drug Administration, Attention: David Serrano, Compliance Officer, Division of West Coast Imports, One 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 # 663674 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us in response to this letter.

Sincerely,
/S/
Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports

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