FDA 483 - Advanced Infusion Solutions - October 27, 2015

The FDA Form 483 details deficiencies in aseptic processing areas, environmental monitoring, personnel monitoring, cleaning, and prevention of contamination.

**Environmental Monitoring Deficiencies:** * On 7/10/2015, Hayes Microbial Consulting identified bacteria (Bacillus, Corynebacterium, Micrococcus, Staphylococcus sp.) and fungus (Cladosporium, unspecified mold) in ISO 7 and ISO 8 areas. * The firm failed to conduct appropriate follow-up investigations or identify organisms/species for colony growth. * Multiple air and contact samples exceeded action levels (e.g., 12 CFUs in ISO 7 gown room, exceeding the >10 action level). * The firm's in-house environmental sampling locations were not equivalent to those of Hayes Microbial Consulting, leading to missed detections in critical areas like the gown room, staging area, anteroom, stock solution room, and transfer handling area. * Environmental monitoring data from July-October 2015 showed colony growth in ISO 5, ISO 7, and ISO 8 areas without adequate investigations. * Surface and air monitoring of the ISO 5 environment are performed weekly, which is deemed inadequate as it's not performed daily when sterile products are produced.

**Personnel Monitoring Deficiencies:** * Personnel monitoring is not performed daily when sterile products are produced; management stated it's weekly, but documentation was