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WARNING LETTER

J&B Food Consulting MARCS-CMS 720186 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Jay J. Lee
Recipient Title
CEO
J&B Food Consulting

380 W. Pebble Beach Ave
La Habra, CA 90631-2000
United States

Issuing Office:
Office of Inspections and Investigations

United States

March 27, 2026

WARNING LETTER

Re: CMS # 720186

Dear Mr. Lee:

From September 11, 2025, through September 18, 2025, the U.S. Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of J&B Food Consulting, located at 380 W. Pebble Beach Avenue, La Habra, CA 90631-2000, serving as the United States (U.S.) agent for (b)(4). 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, Part 1, Subpart L (21 CFR part 1, subpart L). As the FSVP U.S. agent (b)(4), J&B Food Consulting constitutes an importer for purposes of the FSVP regulation (see 21 CFR 1.500).1 As of the date on this letter, we have not received any responses from you following this inspection.

The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the U.S. 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.

The inspection was initiated due to findings of Salmonella in six (6) samples, collected and analyzed by FDA, from several pet treat products imported by your company and manufactured by (b)(4). These six (6) samples were collected by FDA between October 3, 2024, and April 16, 2025. FDA considers the lots of animal food from which these samples were collected to be adulterated under section 402(a)(1) of the FD&C Act [21 U.S.C. 342(a)(1)], in that they bear or contain a poisonous or deleterious substance which may render them injurious to health. Following the positive sample results, these (b)(4) suppliers were placed on Import Alert #71-04, “Detention Without Physical Examination of Food for Animals Due to the Presence of Salmonella,” and/or Import Alert #72-03, “Detention Without Physical Examination of Pig Ears and Other Pet Treats Due to the Presence of Salmonella,”2 between December 4, 2024, and May 19, 2025.

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. 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)].

At the conclusion of the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations, issued on September 18, 2025. As of the date on this letter, we have not received your response to the Form FDA 483a.

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 1.502(a).

Specifically, you did not develop, maintain, and follow an FSVP for some animal foods from (b)(4) that you import, including the following foods: Lamb Lung, Pork Femur Bone, and Beef Lung Sticks. Notably, as discussed above, FDA sampled and analyzed the following products from (b)(4), which were found to contain Salmonella:

  • Lamb lung for entry number (b)(4)
  • Pork femur bone for entry number (b)(4)
  • Beef lung sticks for entry number (b)(4)
  • Beef lung sticks for entry number (b)(4)

As a result of these positive sample results, FDA notices of detention were issued on (b)(4) (lamb lung), (b)(4) (pork femur bone), and (b)(4) and (b)(4) (beef lung sticks).

The FSVP regulation requires the importer of a food to verify that their foreign supplier is producing food consistent with relevant FDA food safety requirements. The foreign supplier of a food is the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the U.S. 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 (21 CFR 1.500). Your foreign supplier might not be the entity from which you directly obtain the food you import. If you obtain a food from a foreign warehouse, distributor, broker, or other entity that does not perform manufacturing/processing of a more-than-de minimis nature, the foreign supplier would be the last entity in the foreign supply chain that conducts significant manufacturing/processing of the food.

During the inspection, you stated your belief that (b)(4) met the definition of a foreign supplier, and that because (b)(4), the firm would be subject to the modified FSVP requirements in 21 CFR 1.513 based on the food safety systems recognition arrangement between (b)(4) and FDA. However, as our investigator explained, (b)(4) does not perform any manufacturing/processing of a more than de minimis nature as they only add labeling; therefore, they are not the foreign supplier for purposes of the FSVP regulation (see 21 CFR 1.500). Additionally, the systems recognition arrangement (b)(4) and FDA does not cover articles of food for animals.

2. You did not promptly investigate and document your investigation to determine whether your FSVP is adequate and, when appropriate, modify your FSVP after you determined by means other than the verification activities conducted under 21 CFR 1.506 or a reevaluation conducted under 21 CFR 1.505(c) or (d), that a foreign supplier of food that you import does not produce 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, as applicable, and the implementing regulations, or produces food that is adulterated under section 402 of the FD&C Act, as required by 21 CFR 1.508(b).

Specifically, you did not promptly investigate and document your investigation to determine whether your FSVP is adequate after FDA sampled and analyzed (b)(4) with entry number (b)(4) that you imported from (b)(4) and found the product to contain Salmonella. As a result of the sample findings, FDA issued a notice of detention dated (b)(4).

During the inspection, you were unable to provide documentation that you undertook such an investigation as a result of the sample findings and detention.

3. You did not conduct a written 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, as required by 21 CFR 1.504(a).

Specifically, you did not provide a hazard analysis, or documentation that you reviewed and assessed a hazard analysis conducted by another entity, for the following products that your import: Pork Femur Bone from (b)(4), Beef (b)(4) from (b)(4), and Raw Hide (b)(4) from (b)(4).

4. You did not meet the requirement to evaluate your foreign supplier’s performance and the risk posed by the food, as required by 21 CFR 1.505(a), and document your approval of your foreign suppliers based on this evaluation, as required by 21 CFR 1.505(b).

Specifically, you did not provide documentation that you evaluated the foreign suppliers’ performance and the risk posed by the food or your approval of the suppliers for any of the foods you import, including Pork Femur Bone from (b)(4), Beef (b)(4) from (b)(4), and Raw Hide (b)(4) from (b)(4). Rather, during the inspection, you stated your belief that (b)(4) met the definition of a foreign supplier and would be subject to the modified FSVP requirements in 21 CFR 1.513 based on the food safety systems recognition arrangement between the (b)(4) and FDA. However, as discussed above, (b)(4) is not the foreign supplier of these products for purposes of the FSVP regulation, and the systems recognition arrangement (b)(4) and FDA does not cover articles of food for animals.

5. You did not establish and follow written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import, as required by 21 CFR 1.506(b).

Specifically, you did not establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted for the following products that you import: Pork Femur Bone from (b)(4), Beef (b)(4) from (b)(4), and Raw Hide (b)(4) from (b)(4). During the inspection, you were unable to provide any copies of written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import.

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 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 to the above violations, we also have the following comments:

  • A Qualified Individual must develop your FSVP, which must include the following documents under the standard requirements:
    o The written hazard analysis and evaluation, as required by 21 CFR 1.504.
    o 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).
    o Documented approval of your foreign suppliers based on the evaluation, as required in 21 CFR 1.505(b).
    o 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).
    o 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).
    o Documentation of the conducted verification activities, as required by 21 CFR 1.506(e).
    o Documented corrective actions, if applicable, as required by 21 CFR 1.508.
  • A Qualified Individual must be able to read and understand the language of any records that must be reviewed in performing an activity, per 21 CFR 1.503(a). During the inspection, you provided a copy of hazard analysis from (b)(4) that was not in English and appeared to be (b)(4). You informed our investigator that you did not understand (b)(4).
  • For more information about FDA’s current thinking on the requirements of 21 CFR part 1, subpart L, see:
    o “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry” https://www.fda.gov/media/118241/download
    o Guidance for Industry #245: “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals” https://www.fda.gov/media/110477/download
    o “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 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 # 720186 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

CC: 

(b)(4)

(b)(4)

_____________________

1 Importer, as defined in 21 CFR 1.500, means the U.S. owner or consignee of an article of food that is being offered for import into the U.S. If there is no U.S. owner or consignee of article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under 21 CFR part 1 subpart L.

2 Import Alert #72-03 was deactivated on April 11, 2025. The firms/products subject to detention without physical examination under Import Alert #72-03 were transferred to Import Alert #71-04 on April 8, 2025. You may view Import Alert #71-04 at: https://www.accessdata.fda.gov/CMS_IA/importalert_217.html.

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