In addition, the investigators observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, our inspection found your facility was not physically designed and environmentally controlled to minimize airborne contamination, and the ISO 5 hood was located in an unclassified area.
This area had no HEPA filters, no air pressure differentials, and the “sterile product compounding room” and the “ante room” were separated by plastic strips that provided no actual “room” separation. Your firm did not adequately monitor and control the microbial and particulate quality of the environment and personnel. Additionally, the flow and handling of materials that were placed in the ISO 5 hood posed an unacceptable contamination hazard. Operators loaded the materials on a tray in the ante-room with bare unsanitized hands and then they carried the tray to an unclassified room. The outer surfaces of these materials were not disinfected prior to entry into the ISO 5 hood. Furthermore, there was no hand washing prior to donning gloves or gowning, and the operators touched non-sterile surfaces and proceeded with aseptic manipulations without sanitizing their gloves. A Form FDA 483 was issued to your firm on March 21, 2014.You have to wash your hands before donning gloves? Who knew?