FDA 483 - WellRx LLC - November 13, 2017

On November 13, 2017, the FDA issued a Form 483 to WellRx, LLC dba HomeRx, LLC, a producer of non-sterile drugs located at 200 East Willow Avenue, Suite 100, Wheaton, IL. The inspection, conducted from October 2, 2017, to November 13, 2017, by Investigator Debra I. Love, identified one observation.

The observation noted that non-pharmaceutical grade components were used in the formulation of human non-sterile drug products. Specifically, non-pharmaceutical grade water was utilized instead of purified USP grade water for several products. Examples provided include C-Diphenhydramine 25mg/5ml liquid produced on August 21, 2017, and July 28, 2017; C-Scopolamine 0.25mg/0.1ml topical lipoderm produced on July 31, 2017; and C-Omeprazole 4mg/ml suspension produced on August 17, 2017. The report was issued to Aileen M. Warren, Pharmacy Manager.