Milwaukee Journal Sentinel
April 5, 2012
One of the nation?s largest makers of alcohol wipes failed to properly test products labeled as sterile months after massive recalls of contaminated wipes shut down a Wisconsin manufacturer, according to newly released federal documents.
The reports from the U.S. Food and Drug Administration show Professional Disposables Inc. of Orangeburg, NY, also failed to ensure equipment cleanliness, train employees and investigate complaints during inspections last summer and fall. Some of the same problems surfaced at the plant going back six years, agency records show.
The company recalled 300 million nonsterile alcohol pads in September after Bacillus cereus was found on its products. The company, which no longer makes nonsterile wipes, later received complaints of the bacterium on its sterile wipes, according to the FDA reports.
The bacterium is the same kind that contaminated wipes from Hartland, WI-based Triad Group and killed a 2-year-old Houston boy. In a lawsuit, the boy?s family blames the Triad Group wipes.
Federal regulators have received reports of 11 deaths possibly connected to Triad?s products. Triad is facing at least 10 lawsuits alleging the product caused illness or death. The company denies its products are responsible and is seeking to resume production.
In December, the Journal Sentinel found three companies that launched recalls because of contaminated wipes in the past year. And in each case, FDA regulators were slow to act. The reports on Professional Disposables were obtained by the newspaper through an open records request.
The New York plant was inspected three times last year alone, and problems were cited each time, the records show. ?The quality of the firm?s investigations (complaints, nonconformances and laboratory) has been a long-standing deficiency with this firm,? FDA inspector Paul Mouris wrote in the October report.
Professional Disposables was cited by the FDA for poor investigations in 2008 and again last year, the report says. Each time, the problems were discussed with management, Mouris wrote, yet it ?is still the exact same deficiency which exists today.?
After each of the inspections, the FDA issued reports pointing out problems in the company?s operations. Professional Disposables responded to those reports in writing. Company officials declined to release that response to the Journal Sentinel or provide other comment Tuesday.
Professional Disposables and the FDA feuded publicly last year over whether to recall the 300 million alcohol pads. The FDA told the Journal Sentinel the New York company promised to recall the contaminated pads in June but failed to launch that recall for nearly four months.
The company maintained the contamination did not pose a risk and blamed the FDA for the delay, saying the recall came after the agency changed its position on how much bacteria is acceptable on a nonsterile product.
The dispute underscored the lack of regulatory power the agency has from Congress on drug recalls, short of going to federal court as the agency did with Triad and its sister company, H&P Industries.
Professional Disposables, which also has a sister company, Nice-Pak, said it ordered the recall last year even though it maintains there was not a risk. The recall is continuing. Besides the current recall, Professional Disposables has had at least two recalls since the beginning of 2010 and also withdrew a product from the market, FDA records show.
The current recall was sparked by a case from May 2011 in which a 27-year-old hemophilia patient developed an infection after he was treated with a Professional Disposables product contaminated with Bacillus cereus, according to a newly released FDA report. The patient was hospitalized and recovered. The company disputed there was a connection between the infection and its product, the report said.
Last year, a company official said Professional Disposables suspected the contamination was connected to one of its suppliers, Tudor Converted Products Inc. of Summerville, SC. Tudor also was a supplier to Triad. PDI declined to say whether it is still using Tudor, adding it considers that proprietary information. Tudor has not responded to requests for comment.
An FDA inspector was back in Professional Disposables? Orangeburg plant in late September?one day after the Journal Sentinel article was published revealing the feud between the company and the FDA.
During the inspection, the FDA reviewed a complaint it received that the company?s sterile alcohol pads were contaminated with Bacillus cereus. The company told regulators it tested the suspected contaminated lots and found no contamination. The FDA performed its own tests, though company officials refused to sign testing paperwork. The FDA test results are not listed in the report, and no recall was initiated.
The inspector found numerous problems in the plant?some of which date back to inspections in 2006, reports show. The FDA issued a report of eight observations?the most among the reports issued against the company in six years.
?The current inspection revealed significant deficiencies within the firm?s Quality Unit,? the inspector wrote. But the FDA has not issued a warning letter or taken other enforcement action against the company.
The FDA report found Professional Disposables was not properly training employees, instead assigning workers to train themselves on their own time online. The company needs to do a better job of cleaning equipment, it said.
The company still had not investigated complaints of leaking packages two months after they were received, according to the FDA report. And the company needs to make sure products it claims to be sterile have been tested, it said. ?Thus, up until 9/2011, the firm was not conducting any sterility testing for Sterile Alcohol Prep Pads as part of their Stability Program,? the report said.
Professional Disposables said it would write a ?commitment letter? to fix some of the problems identified by the FDA.
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