A New York City pharmacy that produces drugs as part of the multibillion-dollar Magellan Health healthcare management corporation was cited in an FDA warning letter for failure to maintain sterile processing procedures.
Based on a December inspection, the FDA flagged several issues at the Magellan Rx Pharmacy, including:
- Deficient design of the sterile drug production area. In one cleanroom, inspectors spotted holes in the ceiling tiles, dust-collecting windowsills and a sink 12 feet from an isolation area.
- The presence of microbial contamination, including fungi and spore-forming bacteria, at multiple locations in a cleanroom.
- Use of non-sterile cleaning wipes and a non-sterile disinfectant in aseptic processing areas.
- Cleanroom workers putting on sterile gloves in an unclassified workspace and wearing jewelry not covered by a gown.