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WARNING LETTER

Safari Stem Cell, LLC MARCS-CMS 661023 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Drugs

Recipient:
Recipient Name
Steven D. Garner
Recipient Title
Owner
Safari Stem Cell, LLC

2402 Marina Bay Drive, Unit E
League City, TX 77573
United States

docgarner@safarivet.com
Issuing Office:
Division of Biological Products Operations II

United States


WARNING LETTER

April 5, 2024

24-661023

Dear Dr. Garner,

The United States Food and Drug Administration (FDA) conducted an inspection of your firm, Safari Stem Cell, LLC (hereafter “Safari”), located at 2402 Marina Bay Drive, Unit E, League City, TX 77573, from May 1, 2023, through May 4, 2023, and found that your firm recovers, processes, and distributes cell- and tissue-based products, including platelet-rich plasma, conditioned media, and stem cells derived from various tissues from canine and feline donors. Your products are intended to treat a variety of diseases or conditions. Examples of routes of administration of your products include, but are not limited to, intravenous, intra-articular, and intrathecal. Your products are used individually or in combination (e.g., adipose-derived stem cells with platelet-rich plasma) and are for autologous, allogeneic, or xenogeneic uses. Statements on your website at the internet address www.stemcellsafari.com, your social media sites https://www.facebook.com/StemCellSafari/, https://vimeo.com/safarivet, and https://www.youtube.com/channel/UCp3IvewLTrwVZNjigZF-d1Q, as well as records gathered during the inspection reflect that your products are intended to treat a variety of diseases and conditions, including, but not limited to, intervertebral disc disease (IVDD), chronic kidney disease (CKD), immune mediated hemolytic anemia (IMHA), diabetes mellitus type II, inflammatory bowel disease (IBD), keratoconjunctivitis, inflammatory disorders such as acute liver failure, and degenerative diseases such as arthritis and hip dysplasia.

We have determined that you are marketing unapproved new animal drugs. The cell- and tissue-based products that Safari markets are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)]. Further, as discussed below, your products are unapproved new animal drugs and your marketing of them violates the FD&C Act.

We acknowledge receipt of your correspondence dated May 12, 2023, in which you stated that your firm would cease operations. However, your website indicates that your firm is still manufacturing and distributing your stem cell products. The webpage entitled “How Can I Get Stem Cells For My Pet As Soon As Possible?” (found at https://stemcellsafari.com/conditions-treated/immunological-disorders/how-can-i-get-stem-cells-for-my-pet-as-soon-as-possible/) provides a phone number and a field for prospective customers to submit contact information and information and medical records about their pet so that they can consult with your firm about your stem cell treatments. The webpage also explains how the treatments can be paid for, shipped, and administered after the consultation.

Statements on your website that show these intended uses of your products include, but are not limited to, the following:

Found at https://stemcellsafari.com/services/stem-cell-therapy/conditions-treated-with-stem-cells/ :

  o “Conditions treated with stem cells
 Arthritis
 Orthopedic Injuries
 Disc Disease/Spinal Cord Injury
 Allergic Skin Disease
 Kidney Disease / Incontinence
 Dry Eye”

  o “Stem Cells For Arthritis
 Stem Cells are injected directly into the joint space when treating arthritis. Studies have shown that these cells have the ability to regrow cartilage identical to the cartilage that may have been damaged in the arthritis”

  o “Intervertebral Disc Disease / Spinal Cord Injury
 Stem Cell Therapy for Disc disease and Spinal Cord Injury can be effective if injected directly into the disc”

  o “Kidney Disease / Incontinence
 Stem cells have shown to regenerate kidney tissue, improve kidney function and reduce metabolite build up.”

  o “Dry Eye” Keratoconjunctivitis Sicca
 This disease is managed by administration of artificial tears and other medications. While it can be managed, it is never cured with medications. Implanted stem cells are well tolerated and were effective reducing clinical signs of KCS in animals with STT values of 0mm – no tear production at all with a sustained effect.”

Found at https://stemcellsafari.com/conditions-treated/immunological-disorders/keratoconjunctivitis-sicca/ :

  o “Keratoconjunctivitis Sicca In Dogs . . .
 Stem cells halt the attack on the tear glands by “resetting” the immune system. This means that your dog can be treated once with stem cell injections into his tear glands and third eyelid, and be resolved of the issue for life.”

Found at https://stemcellsafari.com/conditions-treated/inflammatory-disorders/ :
  o “Stem cells helps the body heal itself by restarting the healing process, rejuvenating damaged tissue and reducing inflammation.”

Found at https://stemcellsafari.com/conditions-treated/immunological-disorders/ :
  o “Immunological Disorders In Pets . . .
 stem cells can “reset” your pet’s immune system and, in most cases, they will resolve their issue for life.”

Found at https://stemcellsafari.com/conditions-treated/degenerative-disorders/ :
  o “Degenerative Diseases In Pets . . .
 Stem cells contain growth factors at levels over 1000 times the normal amount. These growth factors can help stop these degenerative diseases in dogs and reverse them in some cases. Regeneration is the process of reversal of degeneration. Mesenchymal Stem Cells (MSC), Platelet Rich Plasma (PRP), Platelet Rich Plasma Lysate (PRP-L), Autologous Conditioned Serum (ACS) and Conditioned Media (CM) are all regenerative products that can cause regeneration of these tissues.”

Found at https://stemcellsafari.com/conditions-treated/degenerative-disorders/intervertebral-disc-disease/ :
  o “Intervertebral Disc Disease (IVDD) In Dogs . . .
 Stem Cell Treatment For IVDD in Dogs
    o Treating the intervertebral disc disease in dogs with stem cells into the bad discs and/or the spinal canal can prevent disc herniation, as well as treat the existing disease. Stem cells regenerate the cartilage that the discs are made of and draw moisture back inside the disc. The discs become like new, and the owner doesn’t have to watch the dog carefully for signs of the disease returning. Your pet can be treated with one or two stem cell injections, restoring normal function. Note: Safari requires a diagnostic MRI, unless you can present one that is recent and acceptable.”

Found at https://stemcellsafari.com/conditions-treated/degenerative-disorders/chronic-kidney-disease/ :
  o “Chronic Kidney Disease In Dogs And Cats . . .
 Stem cells can restore some of the kidney function that has been lost. Depending on the severity of the condition and when the treatment is given, the kidney values may return to normal or close to normal. Treatment may be injections directly into the kidney or IV injections.”

Found at https://stemcellsafari.com/conditions-treated/immunological-disorders/diabetes-mellitus-type-ii/ :
  o “Diabetes Mellitus Type II . . .
 Stem cells “reset” the pet’s immune system. By injecting stem cells, the pet will live longer, healthier life because their hormonal system will not be on the potential roller coaster ride that comes with the artificial regulation of insulin levels. Your pet can be treated with one or two IV injections of stems cells that can restore the body’s ability to regulate glucose levels. Therefore, your pet will no longer need daily insulin injections!”

Found at https://stemcellsafari.com/conditions-treated/immunological-disorders/inflammatory-bowel-disease/ :
  o “Inflammatory Bowel Disease (IBD) in Dogs and Cats . . .
 Stem cells halt the attack on gastrointestinal system by "resetting” the immune system. With IBD in cats & dogs, the immune system wants to attack the inflammation, but the stem cells sort of put themselves in front of the gastrointestinal walls so that they are attacked, and not the gastrointestinal walls. Meanwhile, the inflammation has a chance to subside, the attack stops, and things return to normal. This means that your dog can be treated intravenously with stem cells and be resolved of the issue, rather than just treating the symptoms with medication for Inflammatory Bowel Disease (IBD) in Dogs.”

Found at https://stemcellsafari.com/conditions-treated/inflammatory-disorders/acute-liver-failure/ :.
  o “Acute Liver Failure In Dogs . . .
 Mesenchymal stem cell (MSC)-based therapy has emerged as a promising strategy for treating liver diseases in dogs via tissue repair and immune regulation.”

From your social media website https://www.facebook.com/StemCellSafari/: Webpage titled – “Stem Cell Safari | League City TX | Facebook”:

  o On your August 18, 2022 post: “This gentle giant got his second round of stem cells today for inflammatory bowel disease. Go (b)(6), (b)(7)(C)!”

  o On your August 11, 2022 post: “(b)(6), (b)(7)(C) the Standard Poodle came all the way from Illinois to get stem cell injections into his kidneys along with intravenous stem cells to help with his chronic kidney disease.

Stem cells reduce inflammation associated with kidney disease and are angiogenic, meaning they are able to grow new blood vessels to help the kidneys. (b)(6), (b)(7)(C) will get a second round of cells in 3-4 weeks, at which time we expect his BUN & creatinine levels to have improved.”

From your social media website https://www.youtube.com/channel/UCp3IvewLTrwVZNjigZF-d1Q , Webpage titled Safari Veterinary Care Centers, additional claims observed, but not limited to, the following:

  o In your “Best Regenerative Stem Cell Therapy Hospital for Dogs in League City Texas,” video dated October 21, 2021 at https://www.youtube.com/watch?v=Qxq71qI61_k, (at the 0:16 timestamp) the video displays: “Regenerative Stem Cell Therapy. For pets suffering with chronic allergies, arthritis, or orthopedic injury, we now offer in-house, adult stem cell therapy to promote joint relief and tissue regeneration...”

  o In your “Treatment of Intervertebral Disc Disease and Stem Cell Therapy for Dogs In League City, TX” video dated Aug 12, 2021 at https://www.youtube.com/watch?v=OF5WYOyGVVU, (at the 0:44 timestamp) the video displays: “Safarivet provides regenerative medicine and stem cell therapy for Dogs in League City, TX. Regenerative medicine strives to use the body’s own healing mechanisms to rebuild damaged or missing tissue.”

From your social media website https://vimeo.com/safarivet, additional claims observed, but not limited to, the following:

  o In “spinal cord injury stem cell therapy” video dated September 18, 2018, at https://vimeo.com/329751292, (at 0:45 – 1:22 timestamp) the video displays: “Treating Intervertebral Disc Disease in Dogs Using Stem Cells . . . If your pet cannot walk today but could walk yesterday then, your pet has Spinal Cord Injury Which could be treated with Stem Cells to make your pet Walk Again . . . ”

  o In “Stem Cells for Disc Disease,” video dated March 20, 2019 at https://vimeo.com/325528141, (at 1:20 – 1:51 timestamp) the video displays: “Stem Cells . . . Decrease Spinal Cord Swelling . . . . Decrease Inflammation . . . Decrease Spinal Scar to Improve Healing . . . Decrease Pain . . . Decrease Neuron Death . . . Stem cells . . . Increase Blood Flow . . . Increase Myelin Life . . . Increase Live Neurons . . . Increase Surgery Success . . . Increase Return to Function . . . Stem Cells . . . SAFE . . . NATURAL . . . EFFECTIVE . . . AFFORDABLE . . .” and (at 2:40 – 2:48 timestamp), “IVDD is a Serious Disease Paralyzing Pets Make Your Decision Now. Choose Stem Cells.”

Because Safari products are intended to diagnose, cure, prevent, mitigate or treat diseases in animals, they are drugs within the meaning of section 201(g)(1)(B) of the FD&C Act, [21 U.S.C. § 321(g)(1)(B)]. Moreover, your products are new animal drugs, as defined by section 201(v) of the FD&C Act, [21 U.S.C. § 321(v)], because they are not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. The products are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. § 360b, 360ccc, and 360ccc-1]. Therefore, the products are unsafe within the meaning of section 512(a) [21 U.S.C. § 360b(a)] of the FD&C Act and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)].

During the inspection, FDA Investigators documented significant deviations from the Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Part 211. These violations cause your animal drug products to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug and Cosmetic Act (FD&C Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with current good manufacturing practice. At the conclusion of the inspection, the FDA investigators issued a Form FDA 483, Inspectional Observations, which described significant CGMP deviations applicable to your products. FDA identified additional significant deviations upon further review of the information collected during the inspection. Specific deviations include, but are not limited to, the following:

1. Failure to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity that they purport or are represented to possess [21 CFR 211.100(a)]. You have not established written procedures that describe the manufacture of stem cells from umbilical cord and bone marrow.

2. Failure to establish and follow written procedures that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch [21 CFR 211.110(a)]. You are required to establish such control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. Our investigation found that you do not validate the manufacturing processes for isolating the stem cells derived from culture expanded adipose tissue, umbilical cord, and bone marrow.

3. Failure to perform appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms [21 CFR 211.165(b)]. Specifically, you failed to perform appropriate laboratory testing, including sterility testing, on at least (b)(4) batches of the stem cell products derived from adipose tissue, umbilical cord, and bone marrow which are administered intravenously or intrathecally.

4. Failure to have a system for monitoring environmental conditions in an aseptic processing area [21 CFR 211.42(c)(10)(iv)]. Specifically, your firm has not established a system for environmental monitoring in the aseptic processing area where stem cell products derived from adipose tissue, umbilical cord, and bone marrow are manufactured.

5. Failure to make, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to the final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. [21 CFR § 211.165(a)]. Specifically, there are no written specifications or procedures that define all analytical or documentation criteria for release for distribution of (b)(4) batches of stem cells derived from adipose tissue, umbilical cord, and bone marrow.

6. Failure to establish and follow written procedures for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product [21 CFR 211.67(b)]. You do not have written cleaning procedures for the manufacturing of your culture expanded allogeneic adipose-derived animal cell product. Furthermore, your firm does not keep cleaning records, as required by 21 CFR 211.67(c).

7. Failure to establish and follow written procedures describing the handling of all written and oral complaints regarding a drug product [21 CFR 211.198(a)] (see also 21 CFR 211.180(e)(2)). Our investigation found that you do not have written procedures for handling or investigating complaints.

8. Failure to prepare batch production and control records for each batch of drug product produced that include complete information relating to the production and control of each batch, including documentation that each significant step in the manufacture, processing, packing, or holding of the batch was accomplished [21 CFR 211.188(b)]. Specifically, your batch production records do not include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding your products or the person(s) performing each of those steps for stem cell products derived from adipose tissue, umbilical cord, and bone marrow.

This letter is not intended to be an all-inclusive statement of violations that may exist 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 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.

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 FD&C Act include your reasoning and any supporting information for our consideration.

Your response should be sent to the following address: Young Mi Yoon, Compliance Officer, U.S. Food & Drug Administration, Office of Biological Product Operations – Division 2, 222 W. 7th Avenue, #25, Room 122, Anchorage, AK 99513 or emailed to YoungMi.Yoon@fda.hhs.gov. If you should have any questions, please contact Young Mi Yoon, Compliance Officer at (907) 248-8146 x 104 or via e-mail.

Sincerely,
/S/

Karlton T. Watson
Program Division Director
Office of Biological Products Operations – Division 2

 
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