Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy

CLOSEOUT LETTER Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy MARCS-CMS 524550 — April 22, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: Recipient Name Christopher M. Schulte Recipient Title Owner Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy 6506 N. Davis Highway Pensacola , FL 32504-6957 United States Issuing Office: Center for Drug Evaluation and Research United States Mr. Schulte: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (CMS Case #524550; June 28, 2017). We acknowledge that your firm no longer produces sterile drug products. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter. You are expected to take all necessary steps to assure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. If there is any question about this information, please contact Jose R. Lopez, Compliance Officer, at (787) 729-8603 , or by email at JoseR.Lopez@fda.hhs.gov . Sincerely, /S/ CDR John W. Diehl, M.S. Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division II Content current as of: 04/24/2019 Regulated Product(s) Drugs