Regulatory Focus™ > News Articles > FDA: After Recall of 300M Wipes, New York Manufacturer Still Failed to Test Products

FDA: After Recall of 300M Wipes, New York Manufacturer Still Failed to Test Products

Posted 06 April 2012 | By Alexander Gaffney, RAC 

A report issued by the US Food and Drug Administration (FDA) is faulting a New York-based company for failing to test its sterile wipe products even after recalling hundreds of millions of products due to bacterial contamination, reports The Bellingham Herald.

The company, Professional Disposables Incorporated, initiated a recall in September 2011 involving 300 million alcohol pads which were supposed to be sterile but were instead contaminated with Bacillus cerus. That bacterium has already been linked to a number of deaths involving disposable wipes manufactured by another company, reports The Herald.

Professional Disposables was already in a public dispute with FDA last year, reports The Herald, after the company allegedly promised to recall the products, but waited an additional four months to launch the recall.

An additional inspection made in September 2011 by FDA showed the manufacturer to have made little progress in training employees, properly cleaning equipment or testing products for contamination.

"[Up] until September 2011, the firm was not conducting any sterility testing for Sterile Alcohol Prep Pads as part of their Stability Program," the report said, despite the massive recall initiated because of those problems.


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The Bellingham Herald - NY company wasn't testing sterile wipes, FDA records show


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