WARNING LETTER

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

Delivery Method:: VIA Electronic Mail
Product:: Food & Beverages

Recipient:: Recipient Name

Ms. Jerrie S Meek; Recipient Title

Owner; JZ Wholesale, Inc.; 2701 Kelley Hwy
Fort Smith, AR 72904-5349
United States; atozjerrie@gmail.com

Issuing Office:: Human Foods Program; United States

WARNING LETTER

March 9, 2026

Re: CMS # 724047

Dear Ms. Meek:

The United States Food and Drug Administration (FDA) inspected your facility, located at 2701 Kelley Hwy, Fort Smith, AR from August 26, 2025, through August 29, 2025. Your facility holds and distributes various human food products, dietary supplements, animal foods, cosmetics, over the counter (OTC) drugs, and devices. 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. Additionally, FDA collected filth samples from various areas within your facility.

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. You may find the Act and FDA regulations through links on FDA’s home page at http://www.fda.gov.

At the close of the inspection, FDA issued a Form FDA 483 (FDA-483), Inspectional Observations, listing deviations found at your facility. To date, you have not submitted a response to the FDA-483. We are issuing this letter to advise you of FDA’s continuing concerns.

Current Good Manufacturing Practice (21 CFR Part 117, Subpart B)

1. 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). Specifically, during the inspection, our investigators observed widespread evidence of rodent activity, rodent excreta pellets (REPs), rodent gnaw marks in food and food packaging, nesting material, and animal feces throughout the entire facility, including areas where human food are routinely stored. Below are examples of the observations made by the investigators.

On August 26, 2025, the following was observed:

Room (b)(4):
a) 26 REPs on the floor, adjacent to a container of (b)(4) 100% Aloe Vera, Lot Number (b)(4), labeled for human consumption in aisle (b)(4) along the (b)(4) wall,
b) Animal feces adjacent to a pallet of bed sheets in aisle (b)(4),
c) Animal feces on the floor of aisle (b)(4), adjacent to a pallet of non-food items along the (b)(4) wall,
d) Animal feces on the floor next to a pest trap and a pallet of non-food items along the (b)(4) wall of aisle (b)(4),
e) Approximately 50 apparent rodent excreta pellets (AREPs) inside an open box of sleeved styrofoam bowls in aisle (b)(4),

Room (b)(4):
f) Animal feces, in the back corner of aisles (b)(4), along the (b)(4) wall,
g) Approximately 25 REPs on top of or next to one (1) case containing eight (8), five (5) pound packages of (b)(4) Cornmeal, Lot # (b)(4) DEC-20-24 BEST BY SEP-16-15, one (1) case containing twelve (12), two (2) pound packages of (b)(4) Cornmeal, Lot # (b)(4) NOV-30-24 BB AUG -27-25, and cases of (b)(4) coffee, Lot # (b)(4) SEP 2024 (b)(4) in the middle of aisle (b)(4).

A field examination was conducted on the pallet containing cases of (b)(4) Coffee and revealed the following:
i. Layer (b)(4)
Open box containing five (5) packages with approximately nine (9) REPs and cockroach ootheca inside box 5
Layer (b)(4)
Box 1 contained one (1) REP, box 7 contained approximately seven (7) REPS, box 8 contained approximately eight (8) REPS, box 14 contained one (1) REP, box 15 contained one (1) REP, and box 16 contained one (1) REP

h) REPs, gnawing, and apparent rodent grease trails on cases of (b)(4) milk chocolate candy bars, Lot #s (b)(4) and (b)(4), and one (1) case of 27/7-ounce packages and one (1) partial case containing 6/7-ounce packages of (b)(4) candy, Lot #(b)(4), stored on 3rd pallet in the middle of aisle (b)(4).

A field examination was conducted on the pallet containing (b)(4) candy bars and (b)(4) Candy and revealed the following:
i. Layer (b)(4)
Box 4, gnawed holes in product packaging, gnawed product, and apparent rodent grease trails on inner surfaces of packaging,
ii. Layer (b)(4)
Box 4 and box 11, gnawed holes in product packaging and gnawed product, and apparent rodent grease trails on inner surfaces of packaging
iii. Layer (b)(4)
Box 7, gnawed holes in product packaging and gnawed product.

i) Approximately 18 dead apparent insects in an open box containing single-use packages of hair masks in the middle of aisle (b)(4),
j) An empty package of cat food was found on the floor in middle of aisle (b)(4)
k) Approximately ten apparent insect eggs were on the floor in the middle of aisles (b)(4),
l) Approximately 14 AREPs on top of a box of USDA inspected (b)(4) bites on the second pallet in the middle of aisle (b)(4),
m) Animal feces on cases of laundry detergent in the middle of aisle (b)(4)
n) The back wall and floors were covered in soil buildup and spider webs along the (b)(4) wall,
o) Apparent animal grease trails covering a white steel column next to a pile of animal feces in the back corner of aisle (b)(4),

(b)(4) Room
p) More than 50 AREPs on top of cases of fajita sauce located in aisle (b)(4) in the middle area of the room,
q) Approximately 25 AREPs on the bottom section of a wooden pallet storing cases of sparkling beverages located on the second pallet in aisle (b)(4),
r) Approximately 15 REPs directly on top of cases of Snapple beverages stored on the bottom section of the first wooden pallet located in aisle (b)(4),
s) Chewed and empty candy wrappers, and nesting, on floors and pallets next to cases of avocado hot sauce and on top of cases of oven cleaner located in aisle (b)(4) in the middle section of the room,
t) Animal footprints on top of cases of (b)(4) dairy creamer and directly next to canned apple sauce stored in aisle (b)(4) located in the middle section of the room.

(b)(4) Room
u) Animal footprints tracking through reddish liquid on the floor, which was identified as toilet bowl cleaner, near dietary supplements, lemongrass tea, and juice stored in the center of the room. You stated the toilet bowl cleaner leaked onto the floor about one (1) week prior.
v) Two large live traps placed along the north wall and in the middle section of the (b)(4) Room, which management stated are used to catch raccoons and cats,

2. 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).

Specifically, on August 26, 2025, the following was observed:
a) In Room (b)(4) there was a case of (b)(4) Pest Spray stored directly on top of a pallet of (b)(4) Chocolate Candy Bars in aisle (b)(4).
b) In the (b)(4) Room, you stored cases of antifreeze and insect spray directly next to (b)(4) Sugar Cookies.

3. 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). Specifically, throughout the inspection, the following were observed:
a. Cobwebs connected to pallets of food and the building’s wooden columns along the (b)(4) wall,
b. Accumulated dirt and dust in following areas:
i. Room (b)(4): Along the (b)(4) wall, near empty packages of cat food between aisles (b)(4), the walls along the edge in the corner near aisles (b)(4), and the back wall and floors,
ii. (b)(4) Room: Aisle (b)(4) on top of boxes of aerosol cans with shredded candy bar wrappers, aisle (b)(4) on top of boxes of (b)(4) dairy stored directly next to canned apple sauce, and on top of sleeves of styrofoam food bowls,

c. Gaps showing visible light in the structure of the building along the (b)(4) wall in Room (b)(4),
d. An unidentified liquid leaking onto the top and bottom of a carboard box stored next to a pallet of food products in Room (b)(4),
e. A red liquid identified as toilet bowl cleaner spilled on the floor near pallets of food items in the (b)(4) Room,
f. Sitting water along the walking pathway in the (b)(4) Room,
g. Harborage in Room (b)(4), where propane tanks were stored directly next to pet food and spray paint cans sitting on top of or next to office chairs,
h. Damaged ceiling directly above food products in Room (b)(4), Room (b)(4), and the (b)(4) Room, including hanging ceiling insulation with visible damage located in Room (b)(4),
i. The dock door and entrance door to your facility was left open during the inspection dates between August 26 to 29, 2025.

Filth samples:

On August 26 and 27, 2025, FDA collected two (2) filth samples from within your facility (samples INV 1306051 & INV 1306052). FDA analysis of the samples INV 1306051 and INV 1306052 confirmed the presence of rodent hairs, REPS, mammalian fecal matter, live mites, American cockroach ootheca and nymphs, insect fecal matter, frass and moth larva, beetle larva, and beetle leg fragments throughout your facility.¹

We acknowledge that you voluntarily destroyed the pallet of (b)(4) Chocolate Bars on August 27, 2025, and promised that cases containing evidence of pest activity will either be voluntarily discarded or reconditioned. However, since the inspection closed, we have not received any updates related to voluntary destruction and/or reconditioning of items in your facility. 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. You are responsible for investigating and determining the causes of any violations and take prompt actions to correct any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that you comply with all applicable FDA requirements.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

Please notify FDA in writing within fifteen (15) working days of the receipt of this letter of the specific steps and corrections you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to: HFP-OCE-ConventionalFoods@fda.hhs.gov, copying Victoria Palmer, Compliance Officer, at the Victoria.palmer@fda.hhs.gov, or by hardcopy to Food and Drug Administration, Attention: Victoria Palmer, Compliance Officer, Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods Enforcement (HFS-607), 5001 Campus Drive, College Park, MD 20740. If you have questions regarding any issues in this letter, please contact Ms. Palmer by email. Please reference CMS reference #724047 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

Maria S. Knirk, JD, MBA
Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

_______________________

1 Laboratory analysis for samples 1306052 and 1306051 were provided to you on 9/19/2025. At the time, you indicated corrective actions occurred including hiring a pest control company and provided no additional details or supporting documents.