Warning letter · FDA Warning Letters

JZ Wholesale, Inc.: FDA Warning Letter 724047 (Mar 9, 2026)

Agency action: Mar 9, 2026Record ID: fda_warning_-2e0bc60903ca9bac
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What happened

Original notice title

JZ Wholesale, Inc. MARCS-CMS 724047, March 09, 2026

From the archived source record

During the inspection of your facility, FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117), Subpart B. Based on FDA’s inspectional findings and sample analysis results, we determined that the human food products held and distributed from your facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (Act) [21 U.S.C. § 342(a)(4)], in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. We are issuing this letter to advise you of FDA’s continuing concerns. You did not take effective measures to exclude pests from your holding and shipping areas and to protect against contamination of food on the premises by pests, as required by 21 CFR 117.35(c). You did not identify and store a toxic chemical in a manner that protects against contamination as required by 21 CFR 117.35(b)(2). You did not maintain buildings, fixtures, and other physical facilities of your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR 117.35(a). In addition, we have not received any documentation to show you have implemented corrective actions, including but not limited to cleaning and sanitation records, or pest control records. (b)(3)(A) 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 complies with all requirements of federal law, including applicable FDA regulations. (b)(3)(A) The violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products.

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

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Status and source details

Status recorded in the archive
No closeout listed in FDA table
Source checked
Jul 16, 2026
Record revision
b2fb2671ef01

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

Sources, dates, and coverage →

What is affected

Product
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Company
JZ Wholesale, Inc.
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.