FDA 483 - Vital Care Compounder, Inc - May 16, 2019

The FDA Form 483 documents deficiencies at a facility involved in drug product manufacturing, processing, packing, and holding. Several observations are repeat findings.

**Environmental Monitoring and Aseptic Conditions:** * Environmental monitoring, including personnel monitoring, is only conducted every (b)(4). * Pressure in classified rooms has not been monitored or documented since December 2018. * Cleaning records prior to January 2019 are absent and lack contact times for cleaning agents. Triple cleaning after growth in ISO 7 rooms (March 2017, September 2017, March 2018) is not documented. * Non-sterile (b)(4) product is used to clean ISO 5 (b)(4) and laminar flow hoods. * Non-sterile wipes and mop covers are used in classified areas, including inside the (b)(4) and laminar flow hood.

**Personnel and Facility Deficiencies:** * Personnel clothing (gown, mask, hairnet, booties) used in classified areas is not sterile. * The anteroom (ISO 7) is crowded, hindering operations. * Rust is present on the anteroom floor. * No written procedures exist for handling spills or cleaning hazardous drugs/blood-derived components. * Scales for non-sterile products have dirt and rust stains; spatulas are worn, stained,