1. Pink Sheet
  2. >>Compliance
  3. >>Manufacturing

B. Cepacia Hits ICUs Again, Raises Manufacturing Controls Questions

 
• By Bowman Cox

Another outbreak of B. cepacia at hospital intensive care units in multiple states implicates manufacturing and supply chain controls on aqueous non-sterile drug products, particularly for those marketed over the counter under OTC monographs.

CDC Colorized SEM of B Cepacia
B. cepacia strikes again • Source: CDC

The mystery began in June. In one intensive care unit after another, one hospital after another, one state after another, patients on ventilators were contracting serious infections from an opportunistic pathogen best known for rotting onions.

By Aug. 10, the outbreak had expanded to 60 confirmed cases in eight states.

More from Manufacturing

More from Compliance