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  5. Inmar Supply Chain Solutions, LLC - 666158 - 01/30/2024
  1. Warning Letters

WARNING LETTER

Inmar Supply Chain Solutions, LLC MARCS-CMS 666158 —

Delivery Method:
UPS Overnight
Product:
Drugs
Food & Beverages
Medical Devices
Recipient:
Recipient Name
Spencer Baird
Recipient Title
Chief Executive Officer
Inmar Supply Chain Solutions, LLC

1 W. 4th St., Suite 500
Winston-Salem, NC 27101
United States

Issuing Office:
Division of Human and Animal Food Operations West III

United States

WARNING LETTER

January 30, 2024

CMS# 666158

Dear Spencer Baird:

The United States Food and Drug Administration (FDA) inspected your facility, Inmar Supply Chain Solutions, LLC, located at 1131 W Bardin Rd. Ste 131, Arlington, TX 76017 from June 22, 2023 through July 19, 2023. Your facility holds and distributes various human foods; cosmetics; over-the-counter drugs (OTC drugs); and devices. Based on the inspectional findings, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations.

Under section 301(a) of the Act [21 U.S.C. § 331(a), the introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated is a prohibited act. Further, 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, drug, device, or cosmetic, 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 http://www.fda.gov.

We acknowledge your firm initiated a voluntary recall of certain products regulated by the FDA that were stored and shipped to interstate customers from January 1, 2023 through July 19, 2023 due to the presence of rodents and rodent activity at your firm. At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations, dated July 19, 2023. FDA received your written responses to those observations on August 10, 2023 and September 11, 2023. We have reviewed your responses and we discuss your significant violations and your corrective actions below.

Adulterated Human Foods

The inspection of your facility revealed serious violations of FDA’s regulations for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods under Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). These violations cause your human food and dietary supplement products to be adulterated within the meaning of section 402(a)(3) of the Act [21 U.S.C. § 342(a)(3)] in that your products consist in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food, and within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that they have been 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.

1. You did not exclude pests from your facility to protect against contamination of food, as required by 21 CFR 117.35(c). Specifically, our investigators observed evidence of rodent activity, including live rodents, dead rodents in various states of decay, rodent excreta pellets (REP), gnaw marks in food and food packaging, and odors indicative of rodent infestation throughout the entire facility including areas where human food is routinely stored. Further, the following observations were noted by the investigators.

a. Dead rodents along the (b)(4) and in a mechanical trap along the (b)(4).
b. Live rodents exiting a box containing chocolate candy and walking across aisle (b)(4).
c. Signs of rodent gnawed food products:
• Gnawed and spilled meal replacement shakes on Aisle (b)(4) with REP too numerous to count on and under the pallet emitting a foul odor. Flying insects were also observed surrounding the pallet.
• Gnawed chocolate candy in a box containing multiple chocolate products.
• Gnawed cartons of boxed soup on a pallet of multiple food products located in the aisle adjacent to pallet location (b)(4).
• A pallet containing bottled water and a gnawed chocolate bar at pallet location (b)(4).
d. Signs of rodent activity and movement observed throughout the facility include:
• Rodent tracks in dust on a black plastic trash bag in a tote of household items stored along the (b)(4) in the (b)(4) area adjacent to pallets of soda and bottles of salad dressing.
• Rodent tracks in dust on top of a pallet of sparkling water in plastic bottles at pallet location (b)(4).
• Paw prints on wooden pallet located at pallet location (b)(4).
• Rodent tracks in dust on black plastic totes located at pallet location (b)(4) directly next to a pallet of salad dressing in plastic bottles.
e. Ubiquitous presence of rodent excreta pellets (REP) throughout the facility and specifically noted in the following locations:
• REPs too numerous to count were observed on and under the pallet of gnawed and spilled meal replacement shakes that were emitting a foul odor.
• REPs on the floor on the (b)(4) corner of the warehouse in front of the exterior door.
• REPs on the floor at pallet location (b)(4) adjacent to a box containing cheese puff snacks.
• REPs too numerous to count along (b)(4) at pallet location (b)(4).
• REPs in the (b)(4) corner of the warehouse.
• REPs too numerous to count along the (b)(4) near the (b)(4) corner of the warehouse behind pallet location (b)(4).
• REP on a plastic wrapped package of bottled sport beverage located at pallet location (b)(4). Small flying insects were also observed around this pallet.
• REPs on top of pallets located at (b)(4) with unknown contents.
• Apparent rodent hair and REPs too numerous to count at pallet location (b)(4) next to a mechanical trap.
f. In addition to visual observations, FDA documented the following findings:
• FDA collected several samples during the inspection. These samples included human food products (samples 1220261, 1220262, and 1220263) product packaging, and a filth sample (sample 1220260). These samples were submitted to FDA labs for analysis. FDA’s analysis found the presence of gnaw marks in the packaging, flies and fly body parts, and/or REPs in these samples. Further, the filth sample included REPs collected from locations throughout the facility.
• FDA conducted a review of your pest control records between February 15, 2022 and June 26, 2023 which documented the increasing observation of rodents within your facility. During this timeframe, your pest control records document a total of 60 mice and 153 rats being captured. The pest control report dated September 27, 2022 documented the greatest number of mice recovered with 21 mice. Pest control reports dated April 24, 2023 and May 15, 2025 documented the greatest number of rats being captured with a total of 12 for each.

2. You did not maintain 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, insanitary conditions were observed around your facility demonstrating that sanitation and housekeeping operations were inadequate. These insanitary conditions are providing food sources and pest harborage areas for rodents and other pests. The following insanitary conditions were observed:

a. Spilled and putrid food product, including gnawed meal replacement shakes, leaking pallets of soda, putrid gnawed oat milk soup (Sample 1220263)
b. Opened food and food wrappers in boxes of product. Open chocolate bar observed in a pallet with bottled water located at pallet location (b)(4)
c. Three holes in drywall, each approximately 4 inches by 5 inches, were observed in the (b)(4) near the incoming product holding area.
d. A large cardboard tote with loose cat food, a towel, and used plastic wrap labeled “Don’t Touch” was observed in pallet location (b)(4). Your firm stated that there was a cat that had kittens in the facility recently. It was later explained that an employee found kittens in the facility about 8 weeks prior.
e. Rodent excreta pellets universally throughout the facility

In your responses dated August 10, 2023, and September 11, 2023, you state that you have increased contracted pest control service visits at your facility and provided a copy of your Integrated Pest Management Service Program. You report that there was only one dead mouse catch in the (b)(4) food area in the six weeks post-fumigation. You also state that you have retrained personnel on inspection and rejection standards and increased external inspection and maintenance activities for the facility. We will verify the effectiveness of your corrective actions during our next inspection.

Adulterated Human Drugs

During our June 22 to July 19, 2023 inspection of your facility, investigators from the FDA determined that your firm holds and distributes OTC drug products that are adulterated within the meaning of section 501(a)(2)(B) of the Act [21 U.S.C.351(a)(2)(B)] in that the building used in the holding of drug products was not maintained in a clean and sanitary condition as required by 21 CFR 211.56(a) and was infested by rodents, insects, and other vermin. The drug products held at your facility were also adulterated under 501(a)(2)(A) of the Act [21 U.S.C. 351(a)(2)(A)] in that the drug products were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health.

During the inspection, our investigator observed filthy conditions in your facility. We observed significant rodent activity throughout the facility. We observed dead rodents in various areas inside your facility, rodent urine and feces around packages containing drug products, and pungent odors in various areas inside your facility. As you are aware, rodents are disease vectors and goods contaminated with rodent feces and/or urine may cause Salmonella and other infectious diseases. Infants, children, pregnant women, the elderly, and immunocompromised persons are at greatest risk for infection and are more likely to have severe symptoms. Consumers can become infected by handling contaminated drugs, including packaging, and then transferring the bacteria from their hands to their mouth. Additionally, Salmonella on hands or clothes can spread the bacteria to other people, objects, and surfaces.

Products stored at your facility, including adulterated drug products, were shipped to your customers after being held in the above-mentioned conditions. You were aware of a rodent infestation at your facility since at least May 2022, and you continued to ship products, including drug products, to customers up until July 14, 2023, when fumigation of the facility occurred.

In your responses dated August 10, 2023, and September 11, 2023, you state that you have increased contracted pest control service visits at your facility and provided a copy of your Integrated Pest Management Service Program. You also state that you have retrained personnel on inspection and rejection standards and increased external inspection and maintenance activities for the facility. In addition, you note that as part of your process, you destroy any OTC drug products with a compromised consumer package. We will verify the effectiveness of your corrective actions during our next inspection.

Adulterated Devices

Devices have been 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, in violation of 501(a)(2)(A) of the Food, Drug and Cosmetic Act.

Specifically, the devices held at your facility were exposed to significant rodent infestation. Investigators documented signs of rodent gnawing, live rodents, and apparent rodent like urine and scratches on the pallet of adult diapers and tampons. The conditions described above for foods and drugs reflect the general objectionable conditions of the warehouse under which you also held devices regulated by FDA. Additionally, all products in the facility were exposed to a fumigation process from July 14-17, 2023. Although your responses indicated that the devices exposed to the fumigation were destroyed, the responses did not include actions to be taken for FDA regulated products when exposed to future fumigations.

Your responses dated August 10, 2023, and September 11, 2023, are not adequate. The responses focus on activities conducted at the facility on W. Bradin Road and includes information on why your facility should be considered a Food Storage Facility (ambient temperature). In addition, the supporting documentation, such as the FDA Current Good Manufacturing Practices (Sanitation) procedure, INM.RCD4.01 dated 3/6/2021, addresses sanitation and requirements for food products but does not address specific activities and requirements for medical devices.

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. Your firm should investigate and determine the causes of any violations and take prompt actions to correct any violations and bring the products into compliance. It is your responsibility to ensure that your firm complies with all requirements of federal law, including 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 and injunction.

In addition, FDA offers the following comment:

• We observed boxes of products stored on pallets in a manner that makes inspection and cleaning more difficult. Pallets were stored less than 12 inches from each other in the aisles of pallet racks, which hinders the ability to inspect for pest activity and clean between pallets.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps 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 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.

Your written response should be sent to Chad J. Whitwell, Compliance Officer, U.S. Food and Drug Administration at the following email: Chad.Whitwell@fda.hhs.gov (preferred) or you may also mail a hard copy addressed to Chad J. Whitwell, Compliance Officer, U.S. Food and Drug Administration at 1201 Main St, Suite 7200, Dallas, TX 75202. If you have questions regarding any issues in this letter, please contact Mr. Whitwell at 214-253-5328 or by email.

Sincerely,
/S/

Edmundo Garcia, Jr.
Program Division Director HAF West 3

Cc:

Mr. Donald C. Spivey, Sr. Manager Warehouse II
Inmar Supply Chain Solutions, LLC
1131 W. Bardin Rd. Ste. 131
Arlington, TX 76017

Fred Jorgenson, EVP & Chief Legal Officer
Inmar Supply Chain Solutions, LLC
1 W. 4th St., Suite 500
Winston-Salem, NC 27101

(b)(5), (b)(6), (b)(7)(C)

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