The importance of cleanliness and being proactive were the two most important lessons learned following the New England Compounding Center’s practices that led to the nationwide fungal meningitis outbreak, said sterile compounding expert Eric Kastango, MBA, RPh, FASHP.
"This is probably the most catastrophic event that has happened in my lifetime, as it relates to compounding," Kastango said during a web seminar Feb. 20 sponsored by Pharmacy OneSource.
In October 2012, the FDA issued a 483 form to NECC, detailing the filthy conditions of its main clean rooms, gown rooms, prep rooms, and adjacent rooms, as well as observations of vials of methylprednisolone acetate (preservative free) 80 mg/mL from one of the lots known to be contaminated with fungus.
"It's mind-blowing," Kastango said of FDA's findings. "If you have a person in a clean room, you're going to have micro-organisms."
It was noted that the air-conditioning was turned off at 8 pm to 5:30 am in the clean room, according to personnel who were interviewed during the FDA inspections.