FDA Finds Chinese Handwipes Contaminated With Bacteria
August 8th, 2012 // 2:32 pm @ jmpickett
File this under ‘sad irony.’ A Chinese maker of antiseptic wipes was actually distributing a large amount of product that was contaminated with… bacteria. That, essentially, defeats the purpose, as you can imagine. The problem surfaced during an FDA inspection last September at a Jiangsu Province Jianerkang Medical Dressing facility in China and prompted the agency to issue a recall late last month (see this).
Specifically, the FDA collected samples of multiple lots of Zee Antiseptic Wipes and two lots contained Burkholderia cepecia, which is a rather serious bacteria. Ironically, the product labeling says the wipes “help prevent infection in minor cuts, scrapes and burns.†In a display of understatement, the FDA notes in a July 30 warning letter that “the presence of organisms such as Burkholderia cepacia in a product intended to be used for wounds is unacceptable.â€
The problems were no accident, at least according to the FDA letter. The manufacturer failed to validate sterilization processes in its written procedures; failed to investigate failed batches; and overall, “failed to establish scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity,†the FDA writes.
As you may recall, wipes can sometimes be a dirty business. Last year, the FDA filed a consent decree against H&P Industries for a plethora of quality control problems (back story) and, of course, the tough stance taken toward Jianerkang Medical Dressing is in keeping with an agency promise to closely monitor a wide array of Chinese manufacturers and suppliers. The message: to stay out of trouble, its best to have clean hands. But make sure you find a different brand of wipes first.
