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Pharmaceuticals / Inspections and Audits

FDA Warns Home Infusion Company

Nov. 16, 2017

The FDA cited an Illinois provider of home infusion therapy for failing to meet sterile production standards, according to a warning letter from the agency.

The agency inspected the Wood Dale facility of the company, Option Care, in September 2016.

Issues cited in the letter included too-rapid movement of workers in a sterile production area, disrupting airflow and increasing the risk of air-quality degradation; failure to completely disinfect materials as they were moved from areas of lower air quality to those of higher air quality; and less-than-optimal storage of sterile cleaning wipes.

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