CLOSEOUT LETTER
Elanco Animal Health MARCS-CMS 695170 —
- Product:
- Animal & Veterinary
- Recipient:
-
Recipient NameAttention: Jeffrey Simmons
-
Recipient TitlePresident and CEO
- Elanco Animal Health
2500 Innovation Way
Greenfield, IN 46140
United States
- Issuing Office:
- Center for Veterinary Medicine
United States
United States
Dear: Mr. Simmons
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated, January 28, 2025. Based on our evaluation, it appears that you have addressed the violations contained in the Warning Letter. Future FDA surveillance will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the U.S. 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 send 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 #695170.
Sincerely,
/S/
Linda Walter-Grimm, DVM
Director, Division of Pharmacovigilance and Surveillance
Office Surveillance and Compliance
Center for Veterinary Medicine