FDA 483 - Option Care - November 25, 2014

This FDA Form 483 details multiple deficiencies observed during an inspection of a facility producing drug products in an ISO-7 cleanroom with ISO-5 Laminar Air Flow (LAF) hoods.

Key violations include: * **Environmental Control:** Lack of adequate exhaust systems, no positive airflow in the ISO-5 LAF hood, and no measurable pressure differential between the ISO-7 buffer room, ISO-8 ante room, and unclassified areas. A contractor indicated the cleanroom did not meet "Walgreens specs." Recorded pressure and temperature readings for the ISO-8 ante room, ISO-7 buffer room, and ISO-7 chemo rooms were outside acceptable ranges from June to October 2014. * **Sanitation & Housekeeping:** Clutter, dust, and debris were observed under ISO-5 LAF hoods. Written sanitation procedures were not followed, with no documentation of cleaning for exterior workbench surfaces, shelves, tables, bins, totes, stools, cabinet surfaces, and LAF hood exteriors in the ISO-7 buffer room for October 2014. Sporicidals were not used, and dwell time instructions for cleaners were absent. * **Sterile Production Practices:** Procedures to prevent microbiological contamination were not followed; an employee dropped a sterile glove, picked it up, put it on, and proceeded to produce drug product without sanitizing it. * **Quality Control & Monitoring:** Established sampling