Infusion Options, Inc. – FDA 483, Apr 23, 2014

On April 9, 10, 11, 14, 16, and 23, 2014, the FDA inspected Infusion Options, Inc., an outsourcing facility located at 5924 13th Avenue, Brooklyn, New York 11219. The inspection revealed 13 observations regarding deficient aseptic processing, environmental controls, personnel practices, and labeling.

Key violations include: - **Aseptic Processing Deficiencies:** Lack of dynamic smoke studies, inadequate monitoring of room pressure, and direct entry of materials from unclassified areas into the ISO 7 cleanroom. - **Personnel Gowning:** Operators wore non-sterile gowns, eyewear, footwear, and facial masks during aseptic manipulation. Sterile gloves were handled with non-sterile gloves, and operators' faces/heads were not fully covered. Gowning material was particle-shedding. - **Environmental Monitoring:** No daily viable air counts in ISO 5 zones, non-viable particulate monitoring not performed under dynamic conditions, and insufficient microbial testing of work surfaces and operators' gloves. - **Cleaning and Disinfection:** Use of particle-shedding sterile wipes, absence of sporicidal agents for ISO 5 surfaces, and use of non-sterile wipes for cytotoxic drug removal. - **Sterility Assurance:** No media fills/process simulations performed under challenging conditions, and sterility testing of parenteral solutions was not conducted per procedure (e