FDA cites "clear and present danger"

Burkholderia cepacia, a common pathogen, is "a clear and present danger" in pharmaceutical manufacturing, says Lynn Torbeck, a statistics-minded pharmaceutical consultant currently working with the FDA on CDER's Drug Recall Root Cause Research Project. He spoke yesterday during an ISPE webinar (access to an archived version is expected via the ISPE website for a fee.)

Although it's a low-risk contaminant for normally healthy people, B. cepacia yields a high rate of death for those with cystic fibrosis and other immune-deficiency conditions. It can be found in such common products as mouthwash, nasal sprays, skin cream and baby wipes--even in the presence of antimicrobial preservatives. As reported earlier, it was the cause of last month's recall of Vicks Sinex nasal spray.

B. cepacia is a worthy adversary. It's in tap water and dirt, Torbeck says. It will eat Agent Orange, and it forms a biofilm that lets it survive in water. Its presence can be the result of inattention to process details or complacency, and it is difficult to eliminate.

"Now is the time to remove it from pharma manufacturing areas and production areas," says Torbeck. His warning comes out of the ongoing FDA project analyzing data on the root causes of Class I and Class II recalls. The project goal is to minimize the defects and failures leading to recalls.

- here's a project overview
- see our Vicks Sinex coverage

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