Inspections, Compliance, Enforcement, and Criminal Investigations

Ceva Animal Health Pty Ltd 10/29/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Rockville, MD  20855

October 29, 2014
 

WARNING LETTER

Via UPS

Mr. Mark Prikazky
Ceva Animal Health Pty Ltd
11 Moores Rd.
Glenorie New South Wales 2157 Australia
 

Dear Mr. Prikazky:

This letter concerns the marketing of several products under the Nature Vet brand name including, but not limited to, Omoguard Paste, Thiazine 100 Injection, Glucosamine 200 Injection, Gentamax 100 Injection, and Ferrocyl Injection by your firm Ceva Animal Health Pty Ltd. The U.S. Food and Drug Administration (FDA) reviewed your website at the internet address horsemedsonline.com, where you promote and sell these products.

We have determined that the above referenced products are intended for use in the mitigation, treatment, or prevention of disease in animals and/or to affect the structure of function of the body of animals, which makes them drugs under section 201 (g)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)]. Under the FD&C Act, drugs intended for use in animals require an approved new animal drug application unless they are generally recognized as safe and effective. As discussed below, we have determined that these drugs are not generally recognized as safe and effective, and are therefore unsafe under section 512(a)(1) 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)], because you are marketing them without approved new animal drug applications.

Statements on your website and product labeling that show these products are intended for use in the mitigation, treatment or prevention of disease in animals and/or to affect the structure or function of the body of animals include, but are not limited to, the following:

Omoguard Paste
• "Once-daily omeprazole for treatment and prevention of gastric ulcers in horses and foals."

Thiazine 100 Injection
• "Xylazine sedative, analgesic and muscle relaxant"
• "In combination with Ketamine to induce full surgical anaesthesia [sic]. Postanaesthesia [sic] to smooth difficult recoveries."

Glucosamine 200 Injection
• "Anti-Inflammatory, Anti-Arthritic & Chondroprotective Agent for IV Use in Horses."

Gentamax 100 Injection
• "Broad spectrum gentamicin antibiotic"
• " ... indicated in infections in horses, dogs and cats which are known to be responsive to Gentamicin."

Ferrocyl Injection
• " ... an injectible organic arsenic and mineral treatment for anaemias and debilitated states in horses."

The above referenced products are only a sampling of the violative products you are currently marketing. Similarly, the above referenced claims are only a sampling of statements that demonstrate the intended uses of your products.

Because the above referenced products are intended to mitigate, treat, or prevent disease in animals and/or to affect the structure of 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)]. Further, 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.

To be legally marketed, a new animal drug must have 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]. The above referenced products are not approved or index listed by the FDA, and therefore the products are considered unsafe under section 512(a)(1) 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)]. Introduction of an adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

This letter is not intended to be an all-inclusive review of your products and their promotion. It is your responsibility to ensure that all of your products are in compliance with the 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 distlibutors 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 bting your finn 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.

Please direct your response to Dillard H. Woody Jr., Supervisor, Post Market Compliance Team at the U.S. Food and Drug Administration with the Center for Veterinary Medicine, 7519 Standish Place, Rockville, MD 20855-2773. If you have any questions about this letter, please contact Dillard Woody at 240-276-9237.
 

Sincerely,
/S/
EricNelson, Director
Division of Compliance (HFV-230)
Office of Surveillance & Compliance
Center for Veterinary Medicine

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