FDA 483 - MasterPharm LLC - May 06, 2015

The FDA Form 483 inspection identified multiple deficiencies at the facility related to aseptic processing, environmental control, and quality systems.

**Aseptic Processing Deficiencies:** * **Smoke Studies:** Not performed under dynamic conditions for ISO 5 non-hazardous, ISO 7 hazardous, and ISO 5 within ISO 7 clean rooms to verify airflow unidirectionality. * **Clutter:** Observed on an ISO 5 workstation during processing of Morphine/Bupivacaine/Clonidine Intrathecal syringe lot 04-22-2015:53, including plastic bins with alcohol wipes or paper records.

**Environmental Monitoring Deficiencies:** * **Viable Air Counts:** Not performed daily in ISO 5 zones during production; last monitored on 10/29/14 during cleanroom certification. * **Non-Viable Particulates:** Not performed under dynamic conditions in ISO 5 zones; last monitored on 10/29/14 during cleanroom certification. * **Work Surface Testing:** ISO 5 hood surfaces not tested daily for microbial contamination during production or at end of operations. * **Pressure Differentials:** Not continuously monitored during production for ISO 5 non-hazardous, ISO 7 hazardous clean rooms, and their respective anterooms.

**Cleaning and Disinfection Deficiencies:** * **Sporicidal Agents:** Not