FDA Root Cause Analysis Puts Spotlight on Bacteria

An FDA analysis of recalls shows drugmakers may be ignoring a persistent bacteria cited in a recent recall and warning letter.

Burkholderia cepacia is a danger, Lynn Torbeck, contractor for the FDA’s recall root cause research project, said at the Parenteral Drug Association–FDA 2009 Joint Regulatory Conference. It is a common pathogen that can grow in distilled water, Torbeck said. “It forms biofilms ... and water and treatment in manufacturing plants are the primary problem,” he added.

Another part of the problem is complacency. The bacteria is a high risk to immunocompromised people, but industry generally does not consider product contamination a major problem because there is a low risk to healthy people, Torbeck said.
Drug GMP Report