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  5. Accurate RX Pharmacy Consulting LLC - 604449 - 06/16/2022
  1. Warning Letters

CLOSEOUT LETTER

Accurate RX Pharmacy Consulting LLC MARCS-CMS 604449 —

Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
Jeffrey Lyon
Recipient Title
General Manager
Accurate RX Pharmacy Consulting LLC
Optum Infusion Services

15529 College Blvd
Lenexa, KS 66219
United States

Issuing Office:
Division of Pharmaceutical Quality Operations III

United States

Dear Mr. Lyons:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL_604449) issued on September 2, 2020. 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/

Nicholas F. Lyons
Director of Compliance
Division of Pharmaceutical Quality Operations III

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