Johnson Memorial Cancer Center – FDA 483, Aug 5, 2014

The FDA Form 483 details deficiencies at a facility involved in the reconstitution of sterile drug products.

**Facility and Operations:** The facility includes an Ante Room (ISO 7), a Mixing Room (IV Prep), a Chemotherapeutic Room, and ISO 5 hoods used for sterile drug product preparation. Operations include gowning, component preparation, and reconstitution of sterile products.

**Violations and Observations:** * **Contamination Control:** Water stains were observed in the plenum above the Ante Room (ISO 7), with plenum air potentially penetrating the classified room through unsealed openings. Yellowish discoloration was noted on HEPA filters in the chemotherapeutic room. * **Environmental Control:** Differential pressure was not adequately balanced and controlled between clean rooms. Specifically, the Ante Room air pressure to the Mixing Room failed on February 12, 2014 (0.01"w.g. positive vs. 0.02"w.g. min), and the Ante Room air pressure to adjacent uncontrolled space also failed. No visible or audible alarms are present for differential pressure problems. * **Environmental Monitoring:** Air flow pattern studies in ISO 5 hoods under dynamic conditions have not been performed. Personnel monitoring is limited to pharmacy technicians' fingers and is only done on an "as needed" basis. Environmental monitoring (viable and non-viable) of the ISO 5 laminar flow hoods is not performed, despite sterile drug products being manipulated daily