Actavis Laboratories FL, Inc.

CLOSEOUT LETTER Actavis Laboratories FL, Inc. MARCS-CMS 567857 — September 01, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Kristopher J. Preisinger Recipient Title Site General Manager Actavis Laboratories FL, Inc. 4955 Orange Dr. Davie , FL 33314 United States Issuing Office: Dallas District Office United States Mr. Preisinger: The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter # 567857 dated February 1, 2019. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities 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 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 a subsequent inspection or through other means. If you have questions regarding the contents of this letter, you may contact Jamillah Selby, Compliance Officer via phone at 214-253-5218 or email at jamillah.selby@fda.hhs.gov Sincerely, /S/ John W. Diehl, M.S Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division II Content current as of: 09/07/2021 Regulated Product(s) Drugs