FDA 483 - Curia New Mexico, LLC - March 20, 2020

The FDA Form 483 details multiple observations regarding procedures for preventing microbiological contamination of sterile drug products. Operators were observed with goggles having unprotected holes, and reaching above shoulder/head level, potentially generating particles. Sanitizing gloves was done without pausing for pre-determined contact time, and no efficacy program exists for glove/surface sanitization. Operators reused wipe surfaces when cleaning. Environmental sampling of gloves is not always conducted. Operators were observed sitting on benches and chairs in Grade B areas. Detachable gloves in the isolator are not sterile. The SOP for disinfecting aseptic areas does not ensure validated disinfectant contact times. Sterilized parts are packaged in non-hermetically sealed containers, compromising sterility. Environmental monitoring (viable and non-viable air) is not ideally situated to represent filling conditions or optimize detection of contamination, particularly near intervention activities or where vials travel. Investigations into dead insects in manufacturing areas lack verification of preventative actions. Finally, investigations are not opened for particles found during 100% visual inspection of parenteral drugs to determine root cause and implement CAPA.