Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bimeda-incorporated-537669-01312019
Timestamp: 2019-09-16 03:33:32
Document Index: 188120858

Matched Legal Cases: ['§ 321', '§ 331', '§ 321', '§ 321', '§ 360', '§ 360', '§ 351', '§ 331']

Bimeda Incorporated - 537669 - 01/31/2019 | FDA
Bimeda Incorporated - 537669 - 01/31/2019
Bimeda Incorporated MARCS-CMS 537669 — January 31, 2019
Mr. Donal Tierney
Bimeda Incorporated
Floor 1B, The Herbert Building
This letter concerns your firm’s marketing of the products Polyglycan®, Polyglycan®–SA, and Polyglycan®–HV, and A-CYST®. The U.S. Food and Drug Administration (FDA or we) reviewed your Polyglycan® product label and your website in October, 2018, at the internet address www.bimedaus.com where you promote these products and sell these products to distributors. The product label and claims on your website establish that these products are intended for use in the mitigation, treatment, or prevention of diseases in animals and/or to affect the structure or function of the body of animals, which makes them drugs under section 201(g)(1)(B) and 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B) and 321(g)(1)(C)]. As discussed below, these products are unapproved new animal drugs and your marketing of them violates the FD&C Act. As explained further below, under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated violates the FD&C Act.
Statements on your Polyglycan® product label and website that establish these intended uses of your products include, but are not limited to, the following:
“Polyglycan® is a patented formulation designed to replace lost or damaged synovial fluid.”
“It contains naturally-occurring components of the synovia that play a central role in maintaining the homeostatic environment of the joint.”
“Introduce Polyglycan® into the synovial space as a post-surgical lavage, synovial fluid replacement or viscosupplement to assist in the normalization of the joint.”
Polyglycan®–SA
“Polyglycan®-SA is a patented formulation designed to replace lost or damaged synovial fluid.”
“It contains naturally occurring components of the synovia that play a central role in maintaining the homeostatic environment of the joint.”
“Introduce Polyglycan®-SA into the synovial space as a post-surgical lavage, synovial fluid replacement or viscosupplement to assist in the normalization of the joint.”
Polyglycan®–HV
“Polyglycan®-HV is a patented formulation designed to replace lost or damaged synovial fluid.”
“Introduce Polyglycan®-HV into the synovial space as a post-surgical lavage, synovial fluid replacement or viscosupplement to assist in the normalization of the joint.”
“A-CYST is a patented formulation designed for temporary replenishment of the glycosaminoglycan (GAG) layer in the urinary bladder.”
“A-CYST has been designed for use in cystitis to temporarily coat and help replenish the deficient GAG layer on bladder epithelium.”
Because your products are intended to prevent, mitigate, or treat diseases in animals and/or affect the structure or function of the body of animals, they are drugs within the meaning of section 201(g)(1) of the FD&C Act, [21 U.S.C. § 321 (g)(1)]. Although the products are promoted as devices on your website, they do not meet the definition of device in section 201(h) of the FD&C Act because they achieve their primary intended purposes through chemical action within or on the body of animals.
Moreover, these 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. They 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 under 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)]. The introduction or delivery for introduction into interstate commerce of this adulterated drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].
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.
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. 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. You also should include copies of any available documentation demonstrating that corrections have been made.
Please direct your response to the U.S. Food and Drug Administration, Office of Surveillance and Compliance, Division of Compliance, HFV-230, 12225 Wilkins Avenue, Rockville, MD 20852, Attention: Eric Nelson, Director.
Cc: Mr. Gavin Tierney
CEO, Bimeda, Inc.
1 Tower Lane, Suite 2250
60181-4626