WARNING LETTER
DingMoo LLC DBA Dingman’s Dairy
MARCS-CMS 705186 —
August 07, 2025
Delivery Method:
Via Email
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Anthony Belasco, Owner
Recipient Title
Ms. Ann Marie Belasco, President and Owner
DingMoo LLC DBA Dingman’s Dairy
191 Pennsylvania Avenue
Paterson
,
NJ
07503
United States
Issuing Office:
Division of Northeast Imports
United States
WARNING LETTER
8/7/25
Re: CMS Case # 705186
Dear Mr. Anthony Belasco and Ms. Ann Marie Belasco:
On February 7 through February 14, 2025, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of DingMoo LLC, doing business as (DBA) Dingman’s Dairy, located at 191 Pennsylvania Ave, Paterson, NJ 07503. 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 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 inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods you import including, but not limited to,
(b)(4)
from foreign supplier
(b)(4)
, Pistachio Tartufo from foreign supplier
(b)(4)
, frozen desserts from foreign supplier
(b)(4)
, and frozen desserts from foreign supplier
(b)(4)
. Because of these significant violations, your firm is not in compliance with Section 805 of the FD&C Act.
The inspection was initiated in response to a multistate
(b)(4)
outbreak investigation involving
Salmonella
Enteritidis infections linked to
(b)(4)
manufactured by your foreign supplier,
(b)(4)
.
(b)(4)
were subject to a Class 1 recall, initiated on
(b)(4)
. The recall was in response to the
(b)(4)
.
We placed
(b)(4)
from your foreign supplier,
(b)(4)
, on Import Alert #99-19, “Detention Without Physical Examination of Food Products Due to the Presence of
Salmonella
,” on
(b)(4)
. You may view this alert at: https://www.accessdata.fda.gov/CMS_IA/importalert_263.html.
Additionally, we placed all RTE foods from your foreign supplier,
(b)(4)
, on Import Alert #99-43, “Detention Without Physical Examination Of Ready-To-Eat Human Food Products That Appear To Have Been Prepared, Packed, Or Held Under Insanitary Conditions,” on
(b)(4)
. You may view this alert at: https://www.accessdata.fda.gov/CMS_IA/importalert_1168.html.
At the conclusion of the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations. We acknowledge receipt of your response dated March 7, 2025, and we address your response below.
Your significant violations of the FSVP regulations are as follows:
1. You did not establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505, and document your use of these procedures, as required by 21 CFR 1.506(a)(1).
2. You did not establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the foods you import, as required by 21 CFR 1.506(b).
3. You must conduct a written hazard analysis for each type of food you import to determine whether there are any hazards requiring a control, as required by 21 CFR 1.504. Your hazard analysis must identify known or reasonably foreseeable hazards for each type of food you import to determine whether there are any hazards requiring a control (21 CFR 1.504(a)). The analysis of the known or reasonably foreseeable hazards in each food must include biological hazards, chemical hazards, and physical hazards (21 CFR 1.504(b)(1)). Your hazard analysis must include an evaluation of the identified hazards to assess the probability that the hazard will occur in the absence of controls and the severity of the illness or injury if the hazard were to occur (21 CFR 1.504(c)(1)). Although you may meet your requirement to determine whether there are any hazards requiring a control in a food by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, you must document your review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual (21 CFR 1.504(d)). However, for your frozen desserts imported from
(b)(4)
, and
(b)(4)
imported from
(b)(4)
, you did not provide a written hazard analysis.
Your response dated March 7, 2025, stated that for “
(b)(4)
,” the supplier from which you imported
(b)(4)
, you provided documents that you described in part as a “Food safety certificate” that stated there was a food safety plan in place for microbiological hazards and a “Manufacturer’s declaration” that the hazards that are present in the product are microbiological (
Salmonella
). However, to the extent the information in these documents may assist you in conducting a hazard analysis for the respective food, you did not document that you conducted a hazard analysis before the food was imported to determine whether there are any hazards, including microbial hazards such as bacterial pathogens such as
Salmonella
, requiring a control, in accordance with 21 CFR 1.504(a).
Further while you obtained the hazard analysis for your Pistachio Tartufo that you imported from foreign supplier
(b)(4)
, you did not document your review and assessment including that the hazard analysis was conducted by a qualified individual, as required by 21 CFR 1.504(d).
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). Under 21 CFR 1.505(a), you must consider the hazard analysis of the food, the entity or entities that would be significantly minimizing or preventing the hazards requiring a control or verifying that such hazards have been significantly minimized or prevented, the foreign supplier performance, and any other factors as appropriate and necessary. During our inspection, you did not provide documentation that you evaluated your foreign suppliers’ performance and the risk posed by the food, as required by 21 CFR 1.505(a), or your approval of your suppliers, as required by 21 CFR 1.505(b) for any of the foods you import. You told our investigator you were unaware of FSVP requirements because you purchased your imported food from a foreign distributor from whom you relied upon to provide documentation of the product you purchased and subsequently imported. 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 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 (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 any manufacturing/processing of a more-than-de minimis nature, the foreign supplier of the food would be the last entity in the foreign supply chain that conducts significant manufacturing/processing of the food.
We acknowledge that in your response dated March 7, 2025, you provided documents you obtained from each of your suppliers including
(b)(4)
. Your response described the documentation from your foreign suppliers as documents that you used to verify that their products were accepted by Dingman’s Dairy to sell. Your response also stated you paused importing any other products for
(b)(4)
while you receive FSVP training. However, the documentation does not reflect whether you evaluated and approved your foreign suppliers prior to importing food from these suppliers. We will assess the adequacy of your corrective actions at your next inspection.
5. You did not meet the requirement to, before importing a food from a foreign supplier, determine and document which verification activity or activities, as well as the frequency with which the activity or activities must be conducted, are needed to provide adequate assurances that the food you obtain from the foreign supplier is produced in accordance with 21 CFR 1.506(c), as required by 21 CFR 1.506(d). With respect to the requirements of 21 CFR 1.506(e) regarding the performance of foreign supplier verification activities before importing a food from a foreign supplier, while you may rely on third-party food safety audits as part of your foreign supplier verification activities, for food that is subject to one or more FDA food safety regulations, an onsite audit of the foreign supplier must consider such regulations and include a review of the supplier’s written food safety plan, if any, and its implementation, for the hazard being controlled (or, when applicable, an onsite audit may consider relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States), in accordance with 21 CFR 1.506(e)(1)(i)(B). You must also promptly review and assess the results of any verification activity, as well as document your review and assessment, among other requirements (21 CFR 1.506(e)(3)). However, during our inspection you were unable to provide documentation of your determination of appropriate verification activities required per 21 CFR 1.506(d). Further the documents you provided failed to meet the requirements of 21 CFR 1.506(e), as described below.
a. For your
(b)(4)
from
(b)(4)
, during the inspection, you provided a Safety Food Certificate dated 2024-04-02. In your response dated March 7, 2025, you provided additional documents, including:
(b)(3)(A)
; manufacturer’s declaration dated 2024/10/01; and test reports dated 19-09-2024 showing no
Salmonella
was detected in product identified as “
(b)(4)
.” Your response states the documents provided were used to verify that your foreign supplier’s products were accepted by your facility to sell; however, the documents provided were dated after you began importing
(b)(4)
from
(b)(4)
on February 23, 2024.
b. For Pistachio Tartufo from
(b)(4)
, during the inspection, you provided two separate sections of HACCP documents for the
(b)(4)
dated 17/06/2022 and
(b)(4)
, dated 09/01/2024 and analytical results for Tartufo Pistacchio products dated 28/02/2024 and 31/05/2024. In your response dated March 7, 2025, you provided additional documents, including: food certificates from third party audits dated
(b)(4)
;
(b)(3)(A)
; customer letter dated 30/01/2025; health statements for egg products dated 26/09/24; and manufacturer’s declaration dated 02/10/2024, stating ice cream desserts were manufactured in accordance with the
(b)(4)
and/or
(b)(4)
, pastries were cooked throughout to reach a minimum internal temperature of
(b)(4)
°F, as well as
(b)(4)
and supplier of eggs.
c. For frozen desserts from
(b)(4)
, in your response dated March 7, 2025, you provided documents, including: customer letter dated 30/01/2025; certificates from third party audits dated
(b)(4)
; and
(b)(3)(A)
.
d. For frozen desserts from
(b)(4)
, in your response dated March 7, 2025, you provided documents, including: certificate from third party audit dated
(b)(4)
;
(b)(3)(A)
; and food hygiene declaration dated 10/01/2018.
For each of your imported foods and foreign suppliers, your response stated that the provided documents were used in verifying their products were accepted to sell. However, you did not provide a record of your review and assessment of the relevant documents before you imported the foods, as required by 21 CFR 1.506(e). Additionally for the third-party audit certificates you provided, we note they do not indicate that they assessed compliance with FDA food safety regulations or reviewed the supplier’s written food safety plan (21 CFR 1.506(e)(1)(i)(B)).
Your response describes that you will no longer have any involvement with products from
(b)(4)
, that you paused purchasing any other products for
(b)(4)
while you receive FSVP training, and that you will no longer carry imported products if your firm cannot implement a stronger program. We will assess the adequacy of your corrective actions at your next inspection.
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 promptly address 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 you import which 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, “Detention Without Physical Examination (DWPE) of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance with the Requirements of the Foreign Supplier Verification Program (FSVP) Regulation,” at: https://www.accessdata.fda.gov/cms_ia/importalert_1160.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: Spiridoula Dimopoulos, Compliance Officer, Division of Northeast, ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) Spiridoul.Dimopoulos@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Dimopoulos via email at Spiridoul.Dimopoulos@fda.hhs.gov. Please reference CMS # 705186 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 Tomao,
Program Division Director
Division of Northeast Imports
Content current as of:
09/16/2025
Regulated Product(s)
Food & Beverages