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Pharmaceuticals / Inspections and Audits

FDA Warns California Compounder for Unapproved Drugs

April 30, 2019

Drug compounder ImprimisRx landed in hot water with the FDA for producing adulterated, misbranded and unapproved drug products at its Irvine, California facility, activity that prompted the agency to issue the firm a warning letter.

An agency investigation, conducted from March 27-31, 2017, was spurred by an adverse event report of a patient’s cardiac arrest and death following an infusion of intravenous curcumin—an anti-inflammatory compound—that contained PEG-40 castor oil, an ungraded inactive ingredient the facility compounded. The castor oil was found to contain diethylene glycol, a known manufacturing impurity.

The product was deemed to be adulterated because it failed to meet quality standards. After analyzing samples of curcumin from an IV bag administered to a patient, as well as the vial of the curcumin emulsion product used to prepare the bag, the agency found the curcuminoid (curcumin and related compounds) concentrations were “substantially less than intended and labeled.”

The facility’s drug products also bore inadequate labeling, as the conditions they were intended for could not be diagnosed or treated by individuals without a medical practitioner background—making them misbranded. Although three of the firm’s drug products contained PEG-40 castor oil, the labeling didn’t reflect this on the list of inactive ingredients.

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