Boehringer Ingelheim Animal Health USA

CLOSEOUT LETTER Boehringer Ingelheim Animal Health USA MARCS-CMS 674535 — September 25, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Animal & Veterinary Recipient: Recipient Name Randolph Legg Recipient Title President and Head of Commercial Business Boehringer Ingelheim Animal Health USA 3239 Satellite Blvd Duluth , GA 30096 United States Issuing Office: Center for Veterinary Medicine United States Secondary Issuing Offices United States Dear Mr. Legg: The Food and Drug Administration has completed evaluation of your firm’s response to our Warning Letter dated March 1, 2024. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during subsequent surveillance or through other means. If you have any questions or comments, please contact Dr. Christopher Loss at christopher.loss@fda.hhs.gov. If you wish to send a response, please direct your response to the undersigned at the Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Pharmacovigilance and Surveillance, 12225 Wilkins Ave, MPN II Room E474, Rockville, Maryland 20852. Please send a courtesy copy by email to CVMSurveillance@fda.hhs.gov. All correspondence should include a subject line that clearly identifies the submission as a Response to Warning Letter # 674535. Sincerely, /S/ Linda Walter-Grimm, DVM Director, Division of Pharmacovigilance and Surveillance Office of Surveillance and Compliance Center for Veterinary Medicine Content current as of: 10/02/2024 Regulated Product(s) Animal & Veterinary