RXQ Compounding LLC – FDA 483, Sep 21, 2015

The FDA inspection of an outsourcing facility revealed multiple deficiencies in aseptic processing, quality control, and record-keeping.

**Aseptic Processing Deficiencies:** * **Air Supply:** A smoke study of the ISO 7 clean room and ISO 5 hood showed smoke egress, indicating a deficient air supply system. Two sterile products, IC-Green 6.25mg/ml Ophthalmic Solution lot#08132015@1 (distributed) and Acetaminophen 10mg/ml Injectable lot#08212015@7 (on sterility test hold), were processed in the affected ISO 5 hood. * **Environmental Monitoring:** The firm failed to frequently monitor differential pressure readings during aseptic production. * **Sterilization Process Validation:** * Media fills for ISO 5 hood personnel did not simulate actual production or challenging conditions, specifically lacking a media fill for the (b)(4) sterilization method used for Acetaminophen 10mg/ml Injectable. * A (b)(4) used for (b)(4) sterilization of Acetaminophen 10mg/ml Injectable lot#08212015@7 was labeled "For research use only, not for in vitro diagnostic or for parenterals." * Depyrogenation validation for finished product vials and (b)(4) sterilization of stoppers, tools,