FDA 483 - Maimonides Medical Center - Pharmacy - July 29, 2019

The FDA Form 483 inspection revealed significant deficiencies in aseptic processing and facility control. Multiple instances of actionable microbial contamination were found in ISO Class 5 and ISO Class 7 areas, including Penicillium, Gram-positive rods, Micrococcus, Bacillus, and Yeasts. Non-microbial contamination was widespread, with observations of damaged, dirty, and discolored HEPA filters, cracks in hood glass shields, and structural damage to floors, walls, ceilings, and doors in cleanrooms. A dirty sticky mat was also noted.

Hazardous and beta-lactam drugs were produced without adequate containment or segregation, leading to potential cross-contamination. Personnel practices were deficient, with observations of gloved hands touching non-ISO 5 surfaces without re-sanitization, exposed body parts during aseptic processing, and the use of non-sterile gloves.

Facility design and operation issues included unclassified areas surrounding ISO 5 hoods in satellite pharmacies, a door that did not close completely, inadequate storage space in the hazardous cleanroom, and a dirty, blocked air return. Sinks were present in cleanrooms. Non-sterile disinfecting agents and wipes were used in ISO 5 areas, and sporicidal agents were not utilized. Equipment and supplies were not disinfected prior to entering aseptic processing areas.

Cleaning and disinfection procedures were inadequate; TPN compounder equipment was not removed for routine cleaning, IV (b)(4) were not cleaned throughout the day, and cleaning logs showed