FDA 483 - University Rx Specialist, dba University Compounding Pharmacy - September 21, 2015

The FDA Form 483 details significant deficiencies in aseptic processing and quality control at a sterile drug product manufacturing facility.

**Environmental Monitoring Deficiencies:** * **ISO 5 & ISO 7 Areas:** Lack of active monitoring for differential pressures, routine viable particulate air, and non-viable particulate air during production. * **Surface Monitoring:** Insufficient frequency of surface sampling in ISO 5 (not done for each lot) and ISO 7 (only beginning, middle, end of day). * **Personnel Monitoring:** Routine personnel glove sampling after daily operations is not conducted.

**Sterility Assurance & Validation Issues:** * **Sterility Failure Investigations:** Failure to thoroughly investigate sterility failures in three drug product batches (Glycerin/Lidocaine/Epinephrine injectable Lot 562655, Heparin/Lidocaine Irrigation Lot #593202, Testosterone pellet Lot #618513), with root causes uninvestigated. * **Media Fills:** Inadequate media fills lacking growth promotion for media, failing to simulate batch processes for large volume vials (100mL/1000mL), and insufficient detail in records (filling time, personnel, equipment, door movements, total time, incubation temperature). * **Clean Hold Time Studies:** Not performed for sterilization glassware. * **Sterile Drug Product Grade:** Sterile drug products are not pharmaceutical grade.