WARNING LETTER
Turkana Food Inc.
MARCS-CMS 711329 —
October 09, 2025
Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Timur Bulag
Recipient Title
Vice President and Owner
Turkana Food Inc.
555 N Michigan Ave
Kenilworth
,
NJ
07033-1076
United States
tbulag@turkanafood.com
Issuing Office:
Division of Northeast Imports
United States
WARNING LETTER
RE: CMS# 711329
Dear Mr. Bulag:
On May 27 through June 06, 2025, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Turkana Food Inc., located at 555 N Michigan Ave., Kenilworth, NJ 07033-1076. We also conducted an inspection on October 04 to November 04, 2024, and June 15 to July 13, 2023. These inspections were 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 most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the following foods you import: Tahini, Halva with Vanilla, Halva with Cocoa and Halva with Pistachio from
(b)(4)
, Tahini from
(b)(4)
, and Crushed Hot Red Pepper Spice from
(b)(4)
all 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 June 23, 2025, and we address your response below.
Your significant violations of the FSVP regulation are as follows:
1. You did not document that you took corrective actions after you determined that a foreign supplier of food you import did 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, if either is applicable, and the implementing regulations, or produced food that is adulterated under section 402 or misbranded under section 403(w) (if applicable) of the FD&C Act, as required by 21 CFR 1.508(a). Specifically, your firm recalled Tahini manufactured by
(b)(4)
in
(b)(4)
that was found to contain
Salmonella
in February 2025, but you did not provide any documentation to show that you took corrective actions as a result of the
Salmonella
finding. Under 21 CFR 1.508(a), the appropriate corrective actions will depend on the circumstances but could include discontinuing use of the foreign supplier until the cause or causes of noncompliance, adulteration, or misbranding have been adequately addressed.
Your response indicated that the foreign manufacturer is conducting a full investigation to determine the root cause of the contamination and to assess any potential effects on other products. As part of your corrective action, you state that you are updating your FSVP records to include supplier communications related to the recall, internal decision-making, and documentation of the investigation outcomes and corrective actions from the supplier. The updates are expected to be completed within 6 months. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your corrective actions.
2. You did not promptly investigate and document your investigation to determine whether your FSVP is adequate after you determined that a foreign supplier of food that you import did 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, if either is applicable, and the implementing regulations, or produced food that is adulterated under section 402 or misbranded under section 403(w) (if applicable) of the FD&C Act, as required by 21 CFR 1.508(b). Specifically, you did not provide any documentation of your investigation to determine if your FSVP is adequate after Tahini manufactured by
(b)(4)
in
(b)(4)
was recalled in February 2025.
Your response indicates that you have conducted a full review and reevaluation of the supplier in question, documented the investigation and findings in a formal “FSVP Adequacy Review Report”, and identified specific gaps in your prior FSVP documentation and implemented updates. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your corrective actions.
3. After you determined that concerns associated with importing a food from a foreign supplier changed, you did not promptly determine and document whether it is appropriate to continue to import the food from the foreign supplier, as required by 21 CFR 1.505(c)(1). Specifically, after Tahini from
(b)(4)
was recalled in February 2025, you continued to import product including Halva with Pistachio, Halva with Vanilla, and Halva with Cocoa which all contain Tahini on April 8, 2025, from the same foreign supplier. During the inspection, you explained to our investigator that after the recall, you decided to slow down the amount of product that you import from
(b)(4)
. However, no documentation supporting this determination was provided.
Your response acknowledges that you continued to import products from
(b)(4)
and indicates that you implemented private laboratory testing of each lot as a temporary mitigation step. You acknowledge that you did not formally assess and document whether it was appropriate to continue to import products from the foreign supplier. For corrective actions, you state that you have documented a formal reassessment of the foreign supplier’s risk status and justification for continued importation, integrated the private lab testing protocol into your updated FSVP plan, and implemented a written SOP requiring any future risk reassessments or mitigation steps to be documented within five business days. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your corrective actions.
4. You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier's performance and the risk posed by a food, as required by 21 CFR 1.505(a)(2). You also did not document your approval of the foreign supplier, as required by 21 CFR 1.505(b). Specifically, you stated in your 483a response for your 2024 inspection that Turkana Foods would discontinue importing from
(b)(4)
in
(b)(4)
as a corrective action due to not receiving FSVP records that were requested. On March 21, 2025, a shipment of products was imported from
(b)(4)
in
(b)(4)
, and you stated that the firm planned to start slow with this foreign supplier again. However, no documentation of approval or an evaluation to determine their performance and the risk posed by their food was provided.
In your response, you acknowledge that the March 2025 shipment should not have proceeded without documenting a new evaluation and approval. Your corrective actions include a post-import full FSVP evaluation of the foreign supplier, revisions to internal FSVP procedures, and a refresher training on FSVP supplier approval protocols. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your corrective actions.
5. You did not 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, as required by 21 CFR 1.504(a). Specifically, you did not provide a hazard analysis for your Crushed Hot Red Pepper Spice from
(b)(4)
in
(b)(4)
and your Tahini from
(b)(4)
in
(b)(4)
.
In your response, you acknowledge that you did not have documented hazard analyses on file for your Crushed Hot Red Pepper Spice from
(b)(4)
in
(b)(4)
and your Tahini from
(b)(4)
in
(b)(4)
. Your response indicates that the hazard analyses have been completed, you have updated your FSVP procedures, and you have provided training on the hazard analysis requirement. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your corrective actions.
6. For a food that contains a hazard that will be controlled by the foreign supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals, you did not conduct or obtain documentation of an onsite audit of the foreign supplier
(b)(4)
after importing the food into the United States, or make an adequate written determination that, instead of such initial and
(b)(4)
onsite auditing, other supplier verification activities and/or less frequent onsite auditing are appropriate to provide adequate assurances that the foreign supplier is producing the food in a manner that significantly minimizes or prevents the hazard requiring a control in the food you import, as required by 21 CFR 1.506(d)(2). Specifically, you did not provide a recent onsite audit or a justification why an audit wasn't performed for your Tahini and Halva with Pistachio from your supplier
(b)(4)
in
(b)(4)
.
For your Tahini from
(b)(4)
in
(b)(4)
, your verification activity is a third party audit and lab testing to be performed
(b)(4)
by the supplier. You provided
(b)(4)
audits for
(b)(4)
factories; however, these audits were dated
(b)(4)
,
(b)(4)
. You did not provide a more recent audit.
In your response, you acknowledge that due to a misalignment with your risk-based verification schedule, you did not perform an
(b)(4)
onsite audit for
(b)(4)
in 2024. You state that you scheduled an onsite audit for
(b)(4)
and that you documented a temporary justification for the lapse. You also acknowledge that you provided an audit for
(b)(4)
that was
(b)(4)
old and stated that you scheduled a new audit for
(b)(4)
and updated your verification schedule. You also state that a new FSVP compliance calendar has been implemented; all verification activities are now logged by supplier, product, and shipment; and you will conduct training on high-risk product verification protocols. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your corrective actions.
7. In approving your foreign suppliers and determining the appropriate supplier verification activities that must be conducted for a foreign supplier of a type of food you import, you did not adequately consider information relevant to the foreign supplier’s compliance with FDA food safety regulations, as required by 21 CFR 1.505(a)(1)(iii)(B). Specifically, you import Tahini from
(b)(4)
located in
(b)(4)
. Your evaluation and approval of this supplier did not adequately consider the foreign supplier's regulatory history and corrective actions for two of the three import alerts on which the foreign supplier is currently listed. Although you provided a corrective action form detailing the foreign supplier’s corrective actions with respect to one of the import alerts, (IA) 99-08 “Detention without Physical Examination of Processed Human and Animal Foods for Pesticides,” you did not evaluate the corrective actions (if any) the foreign supplier took in connection with the other two relevant import alerts, IA 99-19 “Detention Without Physical Examination of Food Products Due to the Presence of Salmonella” and IA 45-02 “Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors.”
Your response indicates that you have obtained written documentation from the foreign supplier and reviewed their corrective actions taken with respect to IA 99-19 and IA 45-02, and updated your Corrective Action Log with this information. You also state that you have updated your “FSVP Evaluation Template” and that you will retrain relevant staff within 2 months on regulatory history review and import alert verification. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation demonstrating your corrective actions.
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 foods you import for which you appear to be in violation of section 805. We may place the foods you import into the United States 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: Stanley Nelson, Compliance Officer, Division of Northeast Imports: oiioiodneiwlresponses@fda.hhs.gov. Please also cc (carbon copy) Stanley.Nelson@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Nelson via email at Stanley.Nelson@fda.hhs.gov. Please reference CMS # 711329 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Sincerely,
/S/
CDR Joseph S. Tomao
Program Division Director
Division of Northeast Imports
Content current as of:
10/28/2025
Regulated Product(s)
Food & Beverages