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  5. One Way Drug LLC dba Partell Specialty Pharmacy - 573455 - 06/16/2020
  1. Warning Letters

CLOSEOUT LETTER

One Way Drug LLC dba Partell Specialty Pharmacy MARCS-CMS 573455 —

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

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