FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Failure to Adhere to Sterile Procedures Brings Warning for Home Infusion Provider

Sept. 27, 2016

Option Care Enterprises received a warning letter from the FDA due to deficiencies in the production of sterile drugs and infusion products at its facility in Everett, Wash.

An investigation by the agency in February found staining on metal grates covering high-efficiency particulate filters, wooden doors (which are harder to clean than metal) separating isolated areas and a technician touching a waste receptacle then performing aseptic operations without disinfecting her gloves.

Additional issues include operators who failed to follow sterile compounding and aseptic technique procedures during the filling of sterile injectable drug products and failure to regularly perform active air sampling for microbiological monitoring in the ISO 5 hoods when sterile drugs were produced.

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