One Way Drug LLC dba Partell Specialty Pharmacy

CLOSEOUT LETTER One Way Drug LLC dba Partell Specialty Pharmacy MARCS-CMS 573455 — June 16, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Drugs Recipient: Recipient Name Robert A. Seik Recipient Title CEO, Owner One Way Drug LLC dba Partell Specialty Pharmacy 5835 S. Eastern Ave. Ste 101 Las Vegas , NV 89119-3031 United States Issuing Office: Division of Pharmaceutical Quality Operations IV United States (949) 608-2900 Dear Mr. Seik: The U.S. Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our warning letter, CMS 573455, dated March 13, 2019. 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 ensure 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. Sincerely, /S/ CDR Steven E. Porter, Jr. Director, Division of Pharmaceutical Quality Operations IV Content current as of: 06/23/2020 Regulated Product(s) Drugs