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

During an FDA inspection from September 8 to October 5, 2020, 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, was cited for four observations.

Observation 1 noted deficiencies in environmental monitoring within aseptic processing areas. Specifically, the firm failed to monitor total particle counts in the ISO 5 area during production from March 2 to October 2, 2020. During this period, (b)(4) batches were produced and (b)(4) batches distributed for patient use, including products like HYDROmorphone, Buffered Lidocaine, ceFAZolin, and fentaNYL/Bupivacaine combinations.

Observation 2 stated that drug products purporting to be sterile and pyrogen-free were not laboratory tested for conformance. The firm did not conduct endotoxin testing prior to releasing sterile drug products, such as fentaNYL/Bupivacaine 250mL bags.

Observation 3 indicated that the outsourcing facility failed to submit a report to FDA identifying all drugs compounded during the previous six-month period. Specific fentaNYL/Bupivacaine products were compounded but not included in the report dated (b)(4).

Observation 4 detailed multiple deficiencies in drug product labeling.