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  5. First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy - 610384 - 02/13/2023
  1. Warning Letters

CLOSEOUT LETTER

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy MARCS-CMS 610384 —

Delivery Method:
VIA EMAIL CONFIRMED DELIVERY
Product:
Drugs
Recipient:
Recipient Name
Dawn T. Hoang
Recipient Title
Co-Owner
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

6828 E. Brown Rd.
Ste. 101
Mesa, AZ 85207
United States

Issuing Office:
Division of Pharmaceutical Quality Operations IV

United States

Dear Ms. Hoang:

The U.S. Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our warning letter, CMS 610384, issued September 8, 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/
CDR Steven E. Porter, Jr. Director, Division of Pharmaceutical Quality Operations IV

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