Option Care Enterprises, Inc. – FDA 483, May 18, 2017

The FDA Form 483 details multiple observations regarding sterile drug production. Non-sterile germicidal detergent is used for cleaning ISO 5 PECs and all ISO 7 work surfaces. A non-sterile reusable device with apparent black particles was used in ISO 5 for Rx TPN 3 in 1 production on 5/9/17. Apparent rust/discoloration was observed on a vial rack in the ISO 5 LFH. Opened, non-sealing packages of sterile wipes were used for cleaning ISO 5 LFHs and disinfecting drug components. Non-sterile material covers ISO 5 work surfaces for hazardous drug production, and non-sterile gown sleeves touched ISO 5 workbenches during sterile drug production on multiple dates. Dust and black particles were observed in the area surrounding ISO 5. ISO 5 areas were not certified under dynamic conditions; smoke studies on 5/5/16 and 11/2/16 lacked production equipment, drug components, containers, and closures. Media plates for environmental and personnel monitoring were not incubated appropriately, with incubator temperatures below manufacturer specifications for environmental samples and personnel samples. Media fill units and gloved fingertip samples were also incubated at temperatures not matching established specifications.