- Animal & Veterinary
- Vetoquinol N.-A.
- Issuing Office:
- Center for Veterinary Medicine
CENTER FOR VETERINARY MEDICINE
Office of Surveillance and Compliance
Division of Compliance, HFV-230
7519 Standish Place
Rockville, MD 20855
June 29, 2017
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter Case # 528109
Dr. Eric Alsup
Vetoquinol USA, Inc.
4250 N. Sylvania Ave.
Fort Worth TX 76137
Dear Dr. Alsup:
On May 13, 2016 and May 16-19, 2016, an investigator from the U.S. Food and Drug Administration (FDA) conducted an inspection of Vetoquinol N.-A. Inc.’s animal drug manufacturing facility located at 700, rue Saint-Henri, Princeville, Quebec, Canada, G6L 4X1. During the inspection of that facility and our subsequent review of your website at www.vetoquinolusa.com, we determined that you are marketing the unapproved new animal drugs Ear Cleansing Solution and Clotrimazole Solution. We also determined that a division of your firm, Tomlyn Products, is marketing the unapproved new animal drug Tomlyn® Ear Cleaner on its website at www.tomlyn.com. As discussed below, your marketing of these unapproved new animal drugs violates the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
The aforementioned products are drugs under section 201(g)(1)(B) the FD&C Act [21 U.S.C. § 321(g)(1)(B)], as they are intended for use in the mitigation, treatment, or prevention of diseases in animals. Statements on the aforementioned websites that establish these intended uses of your products include, but are not limited to, the following:
Ear Cleansing Solution (http://www.vetoquinolusa.com/content/ear-cleansing-solution):
- “Ear Cleansing Solution is gentle enough for routine use with dogs and cats to aid in the prevention of external ear infections.”
- “Ear Cleansing Solution provides an environment that helps maintain healthy ears, and aids in the prevention of external ear infections.”
- “Contains denatured alcohol and lactic acid to dry and acidify the external ear canal”
Clotrimazole solution (http://www.vetoquinolusa.com/products/companion-animals):
- “Antifungal drops and spray for dogs and cats. Recommended for dermatological conditions responsive to Clotrimazole.”
Tomlyn® Ear Cleaner (http://www.tomlyn.com/products/cat-dog/skin-eyes-and-ears/ear-cleaner):
- “Tomlyn's Veterinarian Formulated Ear Cleaner is specially formulated to deodorize and gently clean, dry and acidify the external ear canal.”
- “This provides an environment which promotes maintenance of healthy ears, and aids in the prevention of external ear infections”
The aforementioned 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 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 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.
Please direct your response to the U.S. Food and Drug Administration, 7519 Standish Place, MPN4, Rockville, MD 20855. If you have any questions about the content of this letter, please contact Eric Nelson, Director, Division of Compliance, at Ph: (240) 402-5642 or E-mail: Eric.Nelson@fda.hhs.gov
Center for Veterinary Medicine
cc: Mr. Eric Bernard, Site Director
700, rue Saint-Henri
Princeville, G6L 4X1
Monica Maxwell, FDA, Pharma 2 Division
RP-LBH1 RM455 HFR-PA250
John Diehl, FDA, Pharma 2 Division DCB