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  5. Pan-African Food Distributors Inc./East Africa Boutique LLC - 717171 - 11/13/2025
  1. Warning Letters

WARNING LETTER

Pan-African Food Distributors Inc./East Africa Boutique LLC MARCS-CMS 717171 —

Delivery Method:
Via Email
Product:
Dietary Supplements
Recipient:
Recipient Name
Nicolas C. Kiza
Recipient Title
Owner
Pan-African Food Distributors Inc./East Africa Boutique LLC

2501 Millers Lane Building 3
Louisville, KY 40216
United States

nicolas_kiza@hotmail.com
Issuing Office:
Human Foods Program

United States

November 13, 2025

WARNING LETTER

Re: CMS # 717171

Dear Mr. Kiza:

The United States Food and Drug Administration (FDA), in coordination with the Kentucky Department for Public Health (KDPH), conducted an inspection of your food facility, located at 2501 Millers Lane, Building 3, Louisville, Kentucky, from May 6, 2025 through June 4, 2025. Your facility holds and distributes various foods, including dietary supplements, and cosmetic products. During our inspection of your facility, the FDA investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). In addition, during the inspection, FDA collected filth samples from various areas within your warehouse facility, and the analytical results revealed rodent and insect presence throughout your facility.

Based on FDA’s inspectional findings, we determined that your food products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 342(a)(4)) in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.

Furthermore, it is a prohibited act under section 301(k) of the Act [21 U.S.C. § 331(k)] to do any act with respect to a food or cosmetics, if such act is done while the products are held for sale after shipment in interstate commerce and results in the products being adulterated. You can find the Act and FDA regulations through links on the FDA’s home page at www.fda.gov.

On May 12, 2025, KDPH issued an Order to Cease Operation and Blanket Quarantine for your facility at 2501 Millers Lane, Building 3, Louisville, Kentucky. On May 23, 2025, FDA published a consumer safety advisory informing consumers and retailers not to eat, sell, or serve products distributed by your firm due to insanitary conditions observed at your facility: https://www.fda.gov/food/alerts-advisories-safety-information/fda-advises-consumers-retailers-and-distributors-not-use-eat-sell-or-serve-products-pan-african-food. On May 27, 2025, you initiated a voluntary recall of two food products that had been stored and distributed from your facility. On June 3, 2025, FDA updated the consumer safety advisory due to concerns for all food and cosmetic products held and distributed by your firm.

We acknowledge you conducted voluntary destruction of certain FDA-regulated products onsite at your facility during the inspection. On September 3, 2025, under the oversight of KDPH, you completed voluntary destruction of human food and cosmetic products that had been stored at your facility at the time the Blanket Quarantine was issued on May 12, 2025. As of October 31, 2025, the Order to Cease Operations issued by KDPH on May 12, 2025, for your facility at 2501 Millers Lane, Building 3, Louisville, Kentucky, remains in effect.

At the conclusion of the inspection on June 4, 2025, FDA investigators issued an FDA Form 483 (FDA 483), Inspectional Observations. FDA received your written response, dated June 17, 2025, describing your planned corrective actions. Following review of the inspectional findings and your response, FDA is issuing this letter to communicate our concerns and provide detailed information regarding the findings documented at your facility. Your response is addressed in the sections below.

Your significant violations were as follows:

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

1. You did not take effective measures to exclude pests from your holding areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 117.35(c). FDA investigators observed significant evidence of rodent, insect and animal activity throughout the facility further described below. FDA’s evidence demonstrates live, widespread pest infestations at the time of and prior to our inspection. Additionally, during the inspection, you stated that you (b)(4).

Examples of rodent, insect, and animal activity observed by the investigators in your warehouse over the course of the inspection include, but are not limited to, the following observations:

Rodent activity:

Live and dead apparent rodents observed on multiple dates in the warehouse, including instances where rodents were in direct contact with human food products. Specifically:

  • On May 12, 2025, an apparent rodent was observed exiting a bag of corn meal and running across an investigator’s shoe.
  • On May 12, 2025, a dead apparent rodent was observed on the warehouse floor near where your live pet cat was standing.
  • On May 19, 2025, an apparent rodent was observed on a pallet with cardboard cases containing tomato paste packets.
  • On May 20, 2025, three apparent infant rodents were observed inside a bag of dried shredded edible fumbwa leaves in direct contact with the fumbwa leaves.
  • On May 20, 2025, a dead apparent rodent was observed on a pallet containing bags of maize flour.
  • On May 21, 2025, an apparent rodent was observed on a pallet with cardboard cases containing sorghum flour.

Rodent Excreta Pellets
Apparent rodent excreta pellets (AREPs) in numbers too numerous to count (TNTC) were observed in your warehouse on multiple inspection dates, including May 6 – 21, 2025. Specifically:

  • May 6, 2025, AREPS on the floor and around a pallet containing cardboard cases of mchuzi seasoning mix.
  • May 14, 2025, AREPs on pallets containing cardboard cases of red sorghum flour (intermingled with spilled flour), soybean flour, instant infant cereal, and instant fortified breakfast cereals for older children/adults.
  • On May 15, 2025, AREPs on a pallet containing cardboard cases of cereal for infant/young children.
  • On May 18, 2025, AREPs in a cardboard box containing packets of pondu seasoning.
  • On May 21, 2025, AREPs on pallets containing poly bags of cassava flour and cardboard cases of instant infant cereal.

Rodent Gnaw Holes
Apparent rodent gnaw holes and marks were observed on food packaging (e.g., cardboard cases, poly bags) in your warehouse on multiple dates during the inspection, including damage to a cardboard case of margarine on May 6, 2025, a cardboard case of millet flour on May 14, 2025, and packets of pondu seasoning and a cardboard case of tomato paste on May 19, 2025.

Insect activity:

Live and dead apparent insects were observed in your warehouse on multiple dates during the inspection, including inside your trailer #(b)(4) containing approximately (b)(4) tons of dried sardines in plastic packaging on May 6, 2025, in packages of sorghum flour on May 20, 2025, along the northeast wall of the warehouse, and behind the wallpaper lining the northeast wall on May 21, 2025.

Animal activity:

A domestic cat was observed roaming freely in the warehouse during the inspection. Cat feces and urine were documented on multiple inspection dates, in the warehouse, including on the floor along the exterior of freezer #(b)(4) on May 6, 2025, freezer #(b)(4) on May 7, 2025, and ambient storage on May 20, 2025. In addition, apparent cat urine was observed on pallets containing mango beverages on May 20, 2025. Furthermore, on May 21, 2025, cat feces was observed on top of pallets containing card board cases of candy in the disposal staging area and on the floor in-between two pallets containing cardboard cases of instant fortified breakfast cereals for older children and adults.

Harborage conditions and pest entry points:

Throughout the inspection, harborage conditions of clutter (e.g., binders/books, clothing, luggage, unused pallets, expired food, etc.) were observed along the north wall, northeast corner of the warehouse, and piled in the freezer room in the warehouse. Exposed and spilled food (e.g., flour, dried sardines, cat food, etc.) was observed in the warehouse on multiple dates during the inspection. In addition, the loading dock doors on both the north and south sides of the warehouse were left open on eleven of the twelve inspection dates (May 6-7, 2025, May 12-15, 2025, May 19-21, 2025, and May 28-29, 2025), providing pest entry points.

Filth samples:

On May 12, 2025, FDA collected and analyzed the following samples from areas in the warehouse for filth analysis and found the samples demonstrated the presence of rodent excreta pellets, rodent hairs, cat/dog hairs, and various species of insects (adult stage). Specifically:

  • Sample (b)(4), from the northwest side of the warehouse, demonstrated the presence of rodent excreta pellets, cat/dog hairs, and adult Oryzaephilus surnamensis (sawtooth grain beetle).
  • Sample (b)(4), from a pallet of corn meal, demonstrated the presence of rodent excreta pellets.
  • Sample (b)(4), from bags of roasted soybean flour, demonstrated the presence of adult Tribolium castaneum (red flour beetles).
  • Sample (b)(4), from the southeast freezer room, demonstrated the present of rodent excreta pellets.

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 per 21 CFR 117.35(a). The following deficiencies were observed:

  • On May 6 and May 12, 2025, pallets containing clutter such as bags, sacks, cases, and car parts were stacked too closely together to allow for adequate visual inspection and cleaning access in the warehouse.
  • On May 7, May 20, and May 21, 2025, multiple instances of current and previous water intrusion and structural damage were observed, including:
    o frozen condensation accumulating on and around cardboard cases containing frozen yams due to a damaged overhead refrigeration unit of freezer #(b)(4),
    o staining and damage on the warehouse ceiling in the northeast corner from prior water leakage,
    o water leaking out from freezer #(b)(4) and onto the floor of the warehouse, and
    o damaged ceiling in the freezer room allowing rainwater to enter the warehouse interior.
  • Your freezers, used to store various human foods, were observed in disrepair, including:
    o the exterior wall of freezer #(b)(4) was protruding outward and supported by a piece of wood,
    o damaged ramp leading into freezer #(b)(4) with accumulated buildup of dirt/debris, and
    o damaged interior wall and floor of freezer #(b)(4) with accumulated a buildup of dirt/debris.

3. You did not maintain the grounds around your plant in a condition adequate to protect against the contamination of food by properly storing equipment and removing litter and waste that may constitute an attractant, breeding place, or harborage for pests, as required by 21 CFR 117.20(a)(1). During the inspection, overgrown weeds, piles of unused pallets, accumulated debris/trash, spilled apparent food product, and unused euipment were observed on the grounds surrounding your facility.

We acknowledge your written response, dated June 17, 2025, to the FDA 483, Inspectional Observations. Your written response provided general information about corrective actions you have planned. However, your response does not appear to adequately address each observation and lacks sufficient details regarding corrective actions and implementation deadlines. For example, you indicated (b)(4) but you continue to import human food products without providing a current registered address for your storage and distribution operations, through submission of a food facility registration. Your written response also indicates you (b)(4). However, you have not provided evidence that such actions were taken. We will assess the adequacy and implementation of your corrective actions during a future inspection.

Food Facility Registration:

The FDA has determined that your facility is subject to the registration requirement in section 415 of the Act [21 U.S.C. § 350d] and our implementing regulation at 21 CFR Part 1, Subpart H (21 CFR 1.225 – 1.245). The failure to register a facility as required is a prohibited act under section 301(dd) of the Act [21 U.S.C. § 331(dd)]. Our records indicate that as of the date of this letter, your facility is not currently registered.

As a responsible official of a facility that manufactures, processes, packs, or holds food for consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law. The owner, operator, or agent in charge of your facility, or an individual authorized by your facility's owner, operator, or agent in charge, should register the facility with FDA immediately.

Registration may be submitted electronically at http://www.fda.gov/furls. We strongly encourage the use of electronic format as it is more efficient and provides for immediate submission of the registration information and immediate issuance of the registration number.

Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. This form can be downloaded at: http://www.fda.gov/food/guidanceregulation/foodfacilityregistration/ucm073728.htm or can be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 240-247-8804, or by writing to the agency at the following address: 

U.S. Food and Drug Administration, HFS-681  
Food Facility Registration (HFS-681)  
5001 Campus Drive  
College Park, Maryland 20740

When completed, the form may be faxed to 301-436-2804 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number via email to the facility address provided.

The violations cited in this letter are not intended to be an all-inclusive list of the violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including applicable FDA regulations.

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, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.

In addition to the violations described above, we offer the following comments:

  • We note that you provided our investigators with pest control records from your 3rd party pest control company, and these records covered a timeframe of approximately (b)(4). Overall, the pest control program in place at the time of the inspection was not adequate as evidenced by the live, widespread pest infestations observed. Your written response to the FDA 483 indicates you plan to hire a food safety consultant. However, you have not provided documentation to demonstrate a food safety consultant has been hired. Due to the conditions observed at your facility, including pest infestations, we recommend you hire an outside consultant to address the findings.
  • In addition, some of the products you distribute may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you distribute must comply with applicable statutory and regulatory requirements, including the FD&C Act. A cosmetic is deemed adulterated under section 601(c) of the FD&C Act [21 U.S.C. 361(c)] if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health. Some conditions that cause the food products you distribute to be adulterated may also cause any cosmetics you distribute to be adulterated. We note that under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated.

Further, your facility may be subject to requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.

Please notify FDA in writing within fifteen (15) working days of 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 the Food and Drug Administration, Attention: Carrie Jolly, Compliance Officer, via email at carrie.jolly@fda.hhs.gov or via mail to 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 U.S.A. If you have any questions regarding this letter, you may contact Carrie Jolly, Compliance Officer, via email at carrie.jolly@fda.hhs.gov. Please reference CMS # 717171 on any submissions and within the subject line of any email correspondence to the agency.

Sincerely,
/S/

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

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