FDA 483 - curexa - east, llc - September 09, 2022

The FDA Form 483 details observations from an inspection conducted on a facility producing various drug products, including sildenafil, tadalafil, vardenafil, hydroquinone, naltrexone HCl, and methimazole. The facility includes dedicated rooms for hazardous and non-hazardous compounding.

Multiple instances of non-microbial contamination were observed. Blue powder-like residue was found on wall surfaces, an air conditioning unit, and in crevices within the Nonhazardous Compounding room and an adjacent area on September 1st and 2nd, 2022. This residue was also present inside a hood in the dedicated Non-Hazardous Compounding room, including on agitator shafts and interior walls. Tan and grey residue clumps were noted in non-product-dedicated hoods on August 29th, 2022. Reddish-brown discoloration was observed on a HEPA filter airflow hood in the Nonhazardous Compounding room on September 2nd, 2022.

Cleaning and cross-contamination issues were identified. On September 7th, 2022, a technician failed to use a deactivating or decontaminating agent to clean a spatula after using it for a hazardous product (Hydroquinone) before using it for another hazardous product (C-Testosterone), and then placing it with other utensils. A mixing blade, stored outside the hazardous suite and used for both hazardous and non-hazardous products, was used