FDA 483 - Providence Health and Services Washington Dba Providence Infusion Hospital Services - October 05, 2020

An FDA inspection of Providence Health and Services Washington Dba Providence Infusion Hospital Services in Tukwila, WA, revealed significant deficiencies at their outsourcing facility. Observations included inadequate environmental monitoring in aseptic processing areas, failure to conduct endotoxin testing for sterile drug products, and non-compliance with FDA reporting requirements. Additionally, numerous drug product labels were found to be deficient, lacking critical information such as "This is a compounded drug," dosage form, strength, quantity, and facility contact details.