WARNING LETTER

Quantum Star LLC MARCS-CMS 726568 — August 05, 2026

Delivery Method:: Via Express Delivery
Product:: Food & Beverages

Recipient:: Recipient Name

Arthur M. Nakagawa; Recipient Title

Chief Executive Officer; Quantum Star LLC; 15071 Keswick St
Van Nuys, CA 91405-1133
United States; (b)(6), (b)(7)(C)

Issuing Office:: Office of Inspections and Investigations; United States

August 05, 2026

WARNING LETTER

CMS # 726568

Dear Mr. Nakagawa:

From March 4, 2026 through March 10, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Quantum Star LLC, located at 15071 Keswick St, Van Nuys, CA 91405-1133. 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 Title 21, Code of Federal Regulations (CFR) part 1, Subpart L (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 United States 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.

This inspection follows findings of Salmonella in animal food you import. In (b)(4), FDA sampled and found Salmonella in pig ears imported by your company and manufactured by (b)(4). A subsequent shipment you imported in (b)(4) was also found to contain Salmonella. You were notified of the positive sample results, the pig ears were (b)(4).”¹

During the inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the animal foods you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. 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.²

At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations issued on March 10, 2026. To date, we have not received your response to the Form FDA 483a.

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, you did not develop an FSVP for any of the animal foods you import, including the following foods:

(b)(4) Pig Ears imported from (b)(4), located in the (b)(4).
(b)(4) Pig Ears imported from (b)(4), located in the (b)(4).

We note that the FSVP inspection covered (b)(4) pig ears imported from (b)(4), a manufacturer located in the (b)(4), and shipped by (b)(4), also located in (b)(4), but the manufacturer of this product was transmitted as (b)(4) during importation. You must develop an FSVP for all foods you import from all your foreign suppliers. For the purposes of FSVP, the foreign supplier for an article of food is the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature.³

We also note that, during the inspection, you told the FDA investigator that you identified Salmonella and Listeria as potential hazards and required (b)(4) certificates from your foreign suppliers for each shipment. However, you were unable to provide these certificates or any written hazard analysis. Under 21 CFR 1.504(a), you must conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of food you import to determine whether there are any hazards requiring a control. Your hazard analysis must be written regardless of its outcome.

The above violation is 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 with 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 of the FD&C Act. We may place the foods you import into the United States on detention without physical examination (DWPE) during the time of importation. You can find DWPE information relating to FSVP in Import Alert #99-41 at https://www.accessdata.fda.gov/cms_ia/importalert_1160.html

Additionally, we offer the following comments:

We note that, based on information available to FDA, you may meet the definition of a very small importer under 21 CFR 1.500. Very small importers are required to follow the standard FSVP requirements or the modified requirements under 21 CFR 1.512(b). Under either requirement, a Qualified Individual must develop your FSVP.

Under the standard FSVP requirements, your FSVP must include the following documents:
a. The written hazard analysis, including the identification and evaluation of hazards, as required by 21 CFR 1.504.
b. Documentation of the evaluation (and reevaluation) of your foreign supplier’s performance and the risk posed by the foods, as required in 21 CFR 1.505(a) and 21 CFR 1.505(c) or 21 CFR 1.505(d).
c. Documented approval of your foreign suppliers based on the evaluation, as required in 21 CFR 1.505(b).
d. Written procedures to ensure you import foods only from approved foreign suppliers (or, when necessary, appropriate, and on a temporary basis from unapproved foreign suppliers) and documented use of those procedures, as required in 21 CFR 1.506(a).
e. Determination of appropriate foreign supplier verification activities and written procedures for ensuring the verification activities are conducted, as required by 21 CFR 1.506(b) and 21 CFR 1.506(d).
f. Documentation of the conducted verification activities, as required by 21 CFR 1.506(e).
g. Documented corrective actions, if applicable, as required by 21 CFR 1.508.
Under the very small importer modified FSVP requirements of 21 CFR 1.512(b), you must have the following documents:
a. Annual documentation that you meet the definition of a very small importer, as required by 21 CFR 1.512(b)(1)(i).
b. Written assurance from your foreign supplier before importing the food and at least every two years thereafter, confirming that the supplier produces the food in compliance with processes and procedures providing at least the same level of public health protection as those required under section 418 of the FD&C Act and the implementing regulations (i.e., 21 CFR part 507), and in compliance with the adulteration provisions of the FD&C Act,⁴ as required by 21 CFR 1.512(b)(3)(i).
c. Documented corrective actions, if applicable, as required by 21 CFR 1.512(b)(4).

If you choose to comply with the modified requirements in 21 CFR 1.512, you must still comply with the requirements in sections 1.502, 1.503, and 1.509; however, you do not need to comply with the requirements in sections 1.504 through 1.508 or 1.510.

(b)(3)(A).^{5 , 6}

For more information about FDA’s current thinking on the requirements of 21 CFR part 1, Subpart L, see:

“Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry” https://www.fda.gov/media/118241/download
Guidance for Industry #245: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals” https://www.fda.gov/media/110477/download
“Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP) Regulation Records Requirements” https://www.fda.gov/media/131229/download

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 FDA, Attention: Celena Ngo, 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 Celena Ngo via email at celena.ngo@fda.hhs.gov. Please reference CMS # 726568 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.

Sincerely,
/S/

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

__________________________________

1 (b)(4)

2 See section 301(zz) of the FD&C Act [21 U.S.C. § 331(zz)].

3 See 21 CFR1 .500

4 See section 402 of the FD&C Act [21 U.S.C. § 342].

5 (b)(3)(A).

6 (b)(3)(A).