FDAnews Drug Daily Bulletin

Misbranded and Adulterated Drugs Nets Innovative Compounding Pharmacy Warning Letter

Nov. 15, 2016

The Innovative Compounding Pharmacy (ICP) has received a warning letter after an inspection revealed misbranded and adulterated drug products.

The inspection took place at ICP’s Folsom, Calif. facility in April 2015 and revealed ICP compounded products containing the bulk drug substance domperidone and drug products for which it has not obtained valid prescriptions for individual identified patients. Additionally, the labeling fails to bear adequate directions for their intended uses.

The inspection also revealed that drug products in the facility that were expected to be sterile were prepared, packed, or held under insanitary conditions. Additionally, investigators noticed ICP did not use sterile wipes, lint-free mop heads, or a sporicidal agent as part of the disinfection program to clean the ISO 5 hood and ISO 7 cleanroom where sterile drug products are prepared.

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