FDA 483 - Avenue Pharmacy Inc dba Pathway Pharmacy - September 15, 2014

An FDA inspection conducted from August 26 to September 15, 2014, identified significant deficiencies at Ambient Healthcare of Central Florida Inc., a producer of sterile drugs. The inspection revealed multiple violations related to sterile drug production processes, indicating a lack of adherence to Good Manufacturing Practices. Key issues observed included a failure to follow procedures designed to prevent microbiological contamination, such as not sanitizing items before introduction into ISO 5 hoods. Protective apparel protocols were also inadequate, with a technician observed handling sterile gowns inappropriately and reusing them daily. The facility's environmental monitoring program was found to be severely deficient, lacking daily viable air, surface, and personnel monitoring. Further observations noted the absence of dynamic airflow pattern studies for ISO 5 hoods and an unassessed cleaning and disinfection system for aseptic areas. Critically, no sterility testing had been conducted for distributed sterile drug products like Gentamicin and Cefepime, and there was no written program to assess drug product stability, with unsupported Beyond-Use Dates assigned. To ensure compliance with regulatory standards for sterile drug manufacturing, Ambient Healthcare of Central Florida Inc. must promptly address these critical observations.