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  5. Custom RX LLC dba Custom Rx Pharmacy and Wellness Concepts - 559540 - 01/20/2022
  1. Warning Letters

CLOSEOUT LETTER

Custom RX LLC dba Custom Rx Pharmacy and Wellness Concepts MARCS-CMS 559540 —

Delivery Method:
UPS Next Day
Product:
Drugs

Recipient:
Recipient Name
Jan R. Gerber
Recipient Title
Owner/President and CEO
Custom RX LLC dba Custom Rx Pharmacy and Wellness Concepts

3510 N Ridge Rd.
Suite 900
Wichita, KS 67205-1224
United States

Issuing Office:
Detroit District Office

United States


Dear Mr. Gerber:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (Case #559540), dated October 18, 2018). 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 Branch
Division of Pharmaceutical Quality Operations III

 
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