FDA 483 - biomed pa inc. - July 06, 2017

During an inspection conducted by the FDA from June 28 to July 6, 2017, at Biomed PA Inc. dba Soleo Health, a producer of sterile products, several significant observations were made concerning sterile compounding practices. The inspection documented potential deviations from regulatory expectations, outlined in an FDA Form 483. Key issues included a technician vigorously waving hands within the ISO 5 critical area during the production of Ceftriaxone Sodium, a practice that compromises sterility. Additionally, non-sterile cleaning materials were identified in critical areas: a non-sterile spray bottle was found in the ISO 7 Buffer Room for use in the ISO 5 area, and both disinfecting agents and cleaning wipes used in the ISO 5 area were not sterile. The FDA also noted that the contact time for a sporicidal agent was insufficient to achieve its intended effect, raising concerns about effective decontamination. Biomed PA Inc. dba Soleo Health is required to address these observations by implementing comprehensive corrective actions to ensure the integrity and sterility of its products and maintain compliance with pharmaceutical manufacturing standards.