JMA Partners – FDA 483, Apr 20, 2018

An FDA inspection of Guardian Pharmacy Services in Dallas, TX, a producer of sterile and non-sterile drug products, was conducted from April 2-20, 2018. The inspection revealed 15 observations regarding deficiencies in their manufacturing and quality control systems.

Key observations include: - **Environmental Monitoring:** Aseptic processing areas lacked adequate environmental monitoring. Personnel and ISO 5 surface sampling, required monthly, had not been conducted since December 28, 2017. Semi-annual recertification of ISO 5 hoods, ISO 7 buffer room, and ISO 8 anteroom had not occurred since June 28, 2017. This was a repeat observation. - **Cleaning and Disinfection:** Deficiencies were noted in the system for cleaning and disinfecting aseptic processing areas and equipment. Cleaning records from January 1, 2018, through April 13, 2018, were unavailable. - **Air Recirculation:** Air was recirculated to production areas without adequate dust control. Air visualization pattern testing (smoke studies) for ISO 5 laminar airflow hoods was not documented to ensure unidirectional airflow and proper air recirculation. - **Equipment Design and Maintenance:** An ISO 5 laminar airflow workbench had a non-stainless steel work surface bordered with non-porous particle board, which was not easily cleanable and a potential source of contamination. This was a repeat observation.