Inspections, Compliance, Enforcement, and Criminal Investigations

AniCell Biotech 7/3/18

 

  

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Division of Pharmaceutical Quality Operations IV
19701 Fairchild Road, Irvine, CA 92612-2506
Telephone: 949-608-2900
Fax: 949-608-4417 

 

WARNING LETTER
 
 
VIA SIGNATURE CONFIRMED DELIVERY
 
 
 
July 3, 2018
 
Mr. Brandon T. Ames
AniCell Biotech
145 S 79th St.
Chandler, AZ 85226
 
Dear Mr. Ames:
 
The U.S. Food and Drug Administration (FDA) inspected your facility located at 145 S 79th St. Chandler, AZ, from September 11, 2017 through September 13, 2017. After a review of the establishment inspection report, and a subsequent review of information provided on your website at the internet address: www.anicellbiotech.com, we have determined that you are marketing unapproved new animal drugs. All of the cell-based, regenerative therapy products that AniCell Biotech markets are intended for use in the 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.
 
Statements on your website that show these intended uses of your products include, but are not limited to, the following:
  • “CanisCell Treatments for Dogs”
 o   “CanisCell AniMatrix™ is an acellular implantable amniotic allograft used as a bioscaffold which provides a matrix for wound management of joints and other tissue damage such as orthopedic, bone, muscle, ligament and tendons.”
  • “About AniCell Biotech”
o   “. . . They found that these regenerative treatments can be used the same day as the injury, are able to be used in the field, are more efficacious and safer to use and best of all, less expensive than similar treatments.”
 
o   “. . . This technology is provisionally patented for use in horses and dogs to treat tendons, ligament, hard-to-heal wounds and eyes.”
  • “Frequently Asked Questions (FAQ)”
o   “. . . What can these treatments be used on? These ‘Human Tested, Animal Approved’ products can be used on a host of ailments such as superficial wounds, orthopedic injuries, eye issues such as corneal ulcers and other debilitating joint issues.”
  • “CanisCell StemWrap™”
o   “. . . Due to its natural anti-inflammatory, anti-microbial and anti-adhesion properties, this product reduces the number of dressing changes needed. The amniotic material is placed on the wound and it contains many of the concentrated proteins and collagens needed to accelerate growth and healing.”
 
Because AniCell Biotech products are intended to 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. Your 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) of the FD&C Act, [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. 
 
This letter is not intended to be an all-inclusive review of your products. It is your responsibility to ensure that all of your products are in compliance with the FD&C Act and its implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products. 
 
You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include any documentation necessary to show that correction has been achieved. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made. 
 
Your written response should refer to the Warning Letter Number above (558559). Please address your reply to:
 
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
United States Food and Drug Administration
19701 Fairchild
Irvine, California 92612
 
 
If you have any questions about the content of this letter, please contact Jessica Mu, Compliance Officer, at 949-608-4477 and reference unique identifier CMS 558559 on all correspondence.
           
Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
 
 
Cc:     
David M. Mazzera, Ph.D.
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997413
Sacramento, CA 95899-7413

Page Last Updated: 07/17/2018
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