- Delivery Method:
- UPS Next Day
Recipient NameJan R. Gerber
Recipient TitleOwner/President and CEO
- Custom RX LLC dba Custom Rx Pharmacy and Wellness Concepts
3510 N Ridge Rd.
Wichita, KS 67205-1224
- Issuing Office:
- Detroit District Office
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.
Nicholas F. Lyons
Director of Compliance Branch
Division of Pharmaceutical Quality Operations III