FDA 483 - Providence Health and Services Washington Dba Providence Infusion Hospital Services - April 13, 2022

From March 15 to April 13, 2022, the FDA inspected Providence Health and Services Washington Dba Providence Infusion Hospital Services, an outsourcing facility located at 3333 S 120th Pl Ste 100c, Tukwila, WA 98168-5134. The inspection report, FDA Form 483, was issued to Jacqueline A. Biery, Manufacturing Pharmacy Manager.

The sole observation noted was that the flow of components, drug product containers, closures, and in-process materials through the building is not designed to prevent contamination. Specifically, on March 17, 2022, during the production of ceFAZolin 3 er 30mL Syringe, Lot: [redacted], a compounding technician repeatedly used a cabinet to transfer drug product from an ISO 7 classified Cleanroom to an unclassified room. Additionally, firm management stated that the cabinet leading from the unclassified room to the ISO 7 classified Cleanroom was used multiple times to move items for sterile drug production of ceFAZolin from January 1, 2021, to March 20, 2022. This practice indicates potential contamination risks due to inadequate material flow design between classified and unclassified areas.