FDA 483 - SaveWay Compounding Pharmacy, Inc. - October 02, 2015

The FDA Form 483 documents significant deficiencies in aseptic processing and quality control at the inspected facility.

**Environmental Monitoring and Control:** * Routine/daily environmental or personnel monitoring (personnel, surface, air) is not performed during sterile compounding operations, only approximately every six months, lacking assurance of an aseptic environment. * The curtain separating the ISO Class 7 buffer-room from the ISO Class 7 ante-room has not been evaluated for microbial contamination, is not part of the environmental monitoring program, and lacks a written cleaning/sanitization procedure. * Positive pressure differential between the ISO Class 7 ante/buffer room and the adjacent unclassified segregated compound set-up room is not assured, as room pressure is not monitored in the segregated compounding room.

**Personnel Gowning and Practices:** * Cleanroom gowns are inappropriate for aseptic processing (porous, thin, see-through, easily torn), and their sterility is unassured, with no data to confirm the firm's sterilization process. * Gowning procedures lack requirements for hoods or goggles, leaving exposed skin on the neck and face. Facemasks used are not sterile.

**Sterilization and Aseptic Process Validation:** * Media fill simulations do not represent worst-case conditions, lacking requirements for performance after compounding operations/steps or with maximum personnel. * Smoke studies for the ISO Class 7 buffer-room only evaluated static air-flow