Recipient NameRobert A. Seik
Recipient TitleCEO, Owner
- One Way Drug LLC dba Partell Specialty Pharmacy
5835 S. Eastern Ave.
Las Vegas, NV 89119-3031
- Issuing Office:
- Division of Pharmaceutical Quality Operations IV
- (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.
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV