FDA falls short on safety checks on disposable wipes makers [Milwaukee Journal Sentinel]

Dec. 28--Five years ago, whistleblowers sent a letter to federal regulators warning that contaminated baby wipes were streaming out of an Arkansas factory -- and the Wisconsin-based owner wasn't telling the government or the public.

The two employees wrote to the U.S. Food and Drug Administration that Sheboygan-based Rockline Industries knew of the contamination but continued to ship potentially dangerous wipes to "the hands and bodies of thousands of Americans."

They even warned that plant officials had a code phrase they would broadcast over the intercom -- "Judy Life to the front desk" -- in the event of a surprise inspection.

Two weeks later, on Nov. 7, 2006, an FDA investigator arrived unannounced and found problems including faulty product testing and poor sanitation. Company records show customers had been complaining about mold and foreign objects in the wipes, such as a dead cockroach and razor blade.

Rockline, which makes wipes for retailers under different brand names, announced a nationwide recall later that month of 20 brands of potentially contaminated baby wipes but said they posed little risk.

FDA test results soon came back, proving the suspect wipes were contaminated with Burkholderia cepacia, a bacterium that poses a health risk to anyone with a compromised immune system. The levels were thousands of times higher than FDA and industry guidelines, enough to sicken anyone, even those with healthy immune systems, experts told the Journal Sentinel.

"I wouldn't want to use a wipe with organisms at that level, especially on a baby," said Charles Gerba, a microbiology professor at the University of Arizona and a member of an FDA advisory board.

Industry experts contacted by the Journal Sentinel say the sky-high levels suggested poor manufacturing practices, filthy conditions or both.

The FDA took no enforcement action.

Internally, Rockline worked to find and punish the person top executives referred to as "the mole," doing handwriting analysis and considering DNA samples and fingerprints of workers, records filed in court show.

Now, the same plant is in the midst of recalling the same product, again because of contamination. The FDA has returned and found fresh problems, but once again hasn't taken any enforcement action.

And the public knows even less about this recall.

Rockline, one of the largest makers of baby wipes and coffee filters in North America, is the second Wisconsin company -- and the third nationwide -- to launch recalls of potentially contaminated wipes this year.

The Hartland-based Triad Group was raided by federal agents in April and recalled sterile alcohol wipes used in hospitals and other products. The FDA has received reports of 11 deaths and hundreds of illnesses possibly connected to the use of Triad wipes. New York-based Professional Disposables International is in the midst of its own recall of alcohol prep wipes because of bacterial contamination. A review of case files and an analysis of the FDA's inspection database by the Journal Sentinel shows lax manufacturing practices by the wipes manufacturers, shoddy oversight by the FDA and a failure by anyone to adequately notify the public of health risks.

While the disposable wipes industry has grown rapidly, churning out everyday products that millions use in hospitals and at home, the nation's public health watchdog has not kept up.

The Journal Sentinel found:

--The FDA has not inspected several thousand drug and device makers in at least five years, and hundreds of plants have not seen an inspector in a decade. Despite the whistleblower's warning and serious problems found in the Arkansas plant, Rockline's flagship plant in Sheboygan was last inspected in 1992. FDA records show Rockline's plant in south China and products shipped from there have not been inspected. By law, both plants are supposed to be inspected every two years.

--FDA inspectors found problems at Rockline's Arkansas plant in 2001, in 2006 and again in June -- sometimes in the same areas -- but the agency did not take enforcement action.

--An FDA inspector overlooked key problems in the Arkansas plant in 2006. A bacterium that can cause toxic shock syndrome was listed in company lab results, but not noted in FDA reports. The inspector also failed to note customers had complained about foreign objects in the wipes.

No serious injuries or illness have been definitively linked to the contaminated wipes. However, the only public notice of the current recall has been an item buried deep in the FDA website. If people were sickened, they may not have known the cause.

Rockline officials said they put consumer safety first and denied they knowingly shipped contaminated products. They said as soon as they knew there was a problem they took action. If the problems were serious, they said, the FDA would have taken action.

Rockline president Randy Rudolph says the company has a strong track record for making safe products, and that the problems in Arkansas were an anomaly that led to improvements at all of its plants.

"We are all about doing the right thing, and it's the reason we are having success with our major customers," he said. "I am damn proud of what we do here."

Rockline history

Rockline founder Ralph Rudolph, father of Randy, was a pilot for the German military during World War II before he immigrated to the United States after the war, by his own account. He worked as a janitor when he arrived, later rising to vice president of a Sheboygan-area factory before the plant moved and he was laid off.

Unemployed at 54, he started Rockline in 1976 with a focus on coffee filters. By the mid-1980s sales flattened, but stores soon asked the company to get into a promising new market: Disposable wipes.

In 1989, the family-run company bought a plant owned by Midwest Converting in Springdale, Ark. The plant made moist towelettes and baby wipes for private label customers. Rockline produced the products for others, including Wal-Mart and Roundy's.

Over 15 years, the Arkansas plant expanded from a $5 million-a-year operation to one that brought in more than $150 million in revenue, according to court documents.

The company eventually expanded to six plants -- four in the United States, one in China and one in England -- and raced to the forefront of a billion-dollar industry. The Sheboygan plant added baby wipe production in the 1990s and now has 700 workers. It recently announced a $10 million expansion.

There have been no recalls of products made in the Sheboygan plant, according to FDA records.

The last time FDA was in the Sheboygan plant was 1992, according to agency records -- and that was a mistake. An FDA inspector went to Sheboygan in response to a complaint about wipes made in Arkansas. A report said company leaders knew little about wipes, three years after acquiring the Arkansas

"Randy Rudolph said neither himself or anyone else at the Sheboygan plant are familiar with the baby wipe products or formulas," the 1992 FDA report read.

Patchwork of rules

Disposable wipes are used for everything from combating infectious diseases to cleaning up household messes. Demand for wipes, both consumer and industrial, is forecast to top $2.3 billion in 2014, up from $1.4 billion in 2004.

But as their popularity has surged, the FDA is saddled with a patchwork of rules.

Wipes labeled as sterile are required to be free of bacteria and are classified as drugs, used to treat or prevent diseases. That's because they can come in direct contact with wounds, bloodstreams and spinal fluid. They are tested prior to going on the market, and production plants are supposed to be inspected by the FDA every two years. Wipes also can be considered devices if they are included in an injection kit, for instance.

Non-sterile wipes are not subject to clear bacteria limits but are regulated as a drug if they are anti-bacterial. They are typically used for tasks such as wiping down countertops and cleaning hands.

Other non-sterile products, such as baby wipes, are regulated as cosmetics and are subject to less oversight. When it comes to baby wipes, Congress has left the FDA largely toothless.

Federal law says a cosmetic must not be "adulterated" -- meaning made in unsanitary conditions -- or have high levels of organisms on it.

The agency can take legal action against a company in such cases. But the law does not spell out what conditions or organism levels are violations, leaving each company to set its own standards, microbiologists said.

"Wet wipes are not well-regulated, which has shown itself to be a problem as they are difficult to preserve as a product and difficult to manufacture in a sanitary manner," said Scott Sutton, a New York-based microbiologist who has worked as a consultant to cosmetic manufacturers for 25 years.

Baby wipes are made from non-woven paper material that is soaked in water, with a small amount of sanitizer and preservative. When packaged and sealed, it creates a ripe environment for bacteria growth once contaminated.

Companies are not required to report contamination but are encouraged to notify the FDA of a recall. The agency cannot order a recall of wipes -- sterile or not.

Congress requires the FDA to inspect drug firms every two years, but the Journal Sentinel found that roughly 1,400 drug-making locations have not been inspected in five years or more. FDA officials, who did not dispute the findings, said they focus limited resources on plants that pose the most risk to the public.

As for cosmetic manufacturers, registration is voluntary, and the FDA has no mandate to track or inspect the plants.

FDA manuals suggest examining cosmetic firms that make "high-risk" products such as those used on infants, because they pose "the greatest potential health hazard if they become contaminated with bacteria."

Customer complaints

In 2001, an FDA investigator visited Rockline's Arkansas plant after learning the company was recalling baby wipes because of bacterial growth, agency records show. The company pledged to do a better job keeping the plant clean.

The FDA did not check that promise until 2006. It returned only after receiving the whistleblower letter.

The whistleblowers were ultimately fired. A subsequent lawsuit provided a rare view into the wipes maker's operations by making public a series of internal Rockline documents.

Those documents show Rockline was receiving a stream of customer complaints about mold in 2006.

"This is a very serious situation, and we need to respond immediately to insure (sic) the manufacturing of safe product until we can isolate the exact cause of the contamination," a company memo to the production team read.

Around that time, customers reported finding a razor blade, tape and dead bugs in the wipes. There also were reports of rashes and infections possibly due to the wipes.

Randy Rudolph, the company president, told the Journal Sentinel that mold and bacteria sometimes grow on wipes, if a worker touches the material with a bare hand, water drips from a roof leak or an insect flies through an open plant door.

"You just can't control everything unless maybe it's a sealed plant that is building microchips," he said.

Report of bacterium

In September 2006, Rockline received a report from its outside lab that there was Burkholderia cepacia on its wipes, according to the company records.

That bacterium threatens people with compromised immune systems, is antibiotic-resistant and can live even in alcohol solutions, according to Dave Warshauer, chief bacteriologist at the Wisconsin State Laboratory of Hygiene.

Potentially contaminated wipes were making it to market because the company routinely shipped them before the results of lab testing were available, according to FDA and company documents. Experts said it is very unusual to ship a product before receiving test results.

"I can't imagine releasing without testing," said Phil Geis, a microbiologist who retired after three decades with Procter and Gamble. "You would lose control."

The company received positive results of four different bacteria in September and October 2006, yet no recall was launched and no customers were notified, according to FDA reports and company documents.

Sam Wilson, the plant's human resources director, and Teri Jacques, who worked for him, were alarmed that the company was not telling anyone about the contamination. They sent the whistleblower letter to the FDA in October 2006. They also sent it to Rockline's wholesale customers.

A spokesman for Rockline told the Journal Sentinel the initial test results were contradictory but once the company saw there was a problem, it notified customers and the FDA.

A company official contradicted that statement, saying in sworn testimony that Rockline never notified the FDA of the 2006 recall, court records show. He noted the law did not require it.

FDA records show the agency learned of the contamination from the whistleblower letter, and the FDA didn't know the company was doing a recall until its unannounced inspection.

FDA inspector Janice Hickok arrived at the Springdale, Ark., plant on Nov. 7, 2006 -- two weeks after the whistleblower letter was sent.

She was allowed to look at complaints and lab reports but was blocked by plant officials from copying them.

Rockline spokesman Evan Zeppos said Hickok was not allowed to make copies because of a policy that only employees can use company equipment such as a copy machine.

That kind of defiance has landed other companies in trouble with the FDA, according to Marcia Crosse, head of health care for the General Accountability Office, the investigative arm of Congress.

"That is unusual and would likely be cause for heightened alarm at the agency," Crosse said.

Yet the agency took no enforcement action.

Behind the scenes, plant manager Joel Slank tried to thwart the inspector, according to his assistant.

"I heard Joel Slank on his phone in his office ordering someone at an off-site warehouse to get rid of and destroy that contaminated product before the FDA found where it was located," Pam Ogden said in a deposition taken for one of the whistleblower lawsuits.

Ogden, Slank's assistant, was fired with Wilson and the other whistleblower after they were accused of violating the company's email policy by making unprofessional comments about supervisors. Ogden would only say in a phone interview that everything in her deposition was true.

Hickok wrote in her inspection report that the firm used tap water without additional filtration or treatment. Experts said using plain tap water could contribute to contamination. But there are no rules governing baby wipes manufacturers, only suggestions.

Hickok told the company in November 2006 to cover the assembly line to avoid contamination. Managers said conveyors were not covered at other plants in the industry and refused.

Company records showed a more virulent bacterium, Staph aureus, was found on Rockline wipes twice in 2006. A form of Staph aureus was implicated in the toxic shock syndrome that sickened and killed women through contaminated tampons in the 1970s.

But FDA documents do not even mention that bacterium. It was listed in Rockline's internal lab results -- which the inspector could not copy. The company's lab results were entered in court records through one of the whistleblower's lawsuits.

The FDA test of Rockline wipes revealed levels of a different bacterium, Burkholderia cepacia, that microbiologists interviewed by the Journal Sentinel called "gross contamination."

While federal law does not set a maximum, the FDA has said a cosmetic should not contain an excessive level of bacteria. It quotes industry guidance, which says baby products should not have more than 500 microorganisms per gram.

The Rockline baby wipe tested by FDA showed 97 million to 190 million parts per gram -- thousands of times over that recommended level.

"That is profound," Geis said. "It is about as high as you can get."

Experts said such a high contamination level qualifies as "adulterated," a violation of the cosmetics law. And it could sicken a healthy person, not only someone with a compromised system.

"That is filthy," Sutton said. "It was either manufactured filthy or it is inadequately preserved and allowed low numbers of microorganisms to grow to unacceptable levels."

Zeppos said the Arkansas facility was clean. And he said the plant's use of tap water and its policy to ship before receiving test results were accepted industry practices, despite what the experts told the Journal Sentinel.

"If we were filthy, we would be shut down," he said.

Zeppos said the bacterium levels listed in the FDA test were artificially high because of testing techniques. Microbiologists told the Journal Sentinel that regardless of the exact level, the FDA test indicates the product was adulterated.

"Whether 97,000 or 9.7 million, it is just not relevant," said David Steinberg, a microbiologist and industry consultant who works for Rockline . "It is contaminated. It is a cause for concern."

Zeppos acknowledged problems in the Arkansas plant in 2006 but said the company took swift action.

"We have a strong track record at Rockline that when we make mistakes, we do our lev elheaded best to solve them," he said. "When we find them, we spend millions to fix it."

Ron Johnson, a former FDA official hired by Rockline in the whistleblower lawsuit, told the Journal Sentinel that the company acted correctly during the 2006 recall. He said it was the first major recall in the country of baby wipes for bacteria.

"This episode was problematic. There is no doubt about that," he said. "This occurred and the industry said, 'We need to tighten things up.' "

Hunt for whistleblowers

As the FDA investigated Rockline's 2006 contamination, the hunt was launched in the Arkansas plant for the whistleblowers.

Ralph Rudolph, the company's founder, told executives to spend whatever money they had to, "as long as we find the 'mole,' " according to an email sent to Wilson, one of the whistleblowers.

Wilson wrote back that the private investigator hired by Rockline had interviewed employees and done handwriting analysis and computer searches. Fingerprinting and DNA swabs were next.

Wilson asked if it was legal to take DNA and wondered in an email what Wal-Mart would think.

"Should we not be more focused on fixing the quality issues and the rest will take care of itself?" he wrote.

Wilson and Jacques were fired in early 2008. Both sued in federal court.

Wilson, 68, who worked at Rockline for 15 years, contended in his lawsuit that he was fired because he was a whistleblower and also because he was old. A jury found in Wilson's favor last year, on both complaints. He received $72,000 in back pay and insurance costs. He could not sue under the federal whistleblower law because he worked for a private company. Under Arkansas law, he was not allowed to sue for punitive damages. Jacques' case is pending.

Wilson could not be reached for comment.

Randy Rudolph told the newspaper that Wilson was an unstable man who tried to hurt the company, and his letter to FDA was riddled with inaccuracies.

"Sam Wilson was a very disgruntled employee," Rudolph said. "I would not put stock into his comments."

New recalls

In 2007, Rockline issued a new recall of wipes from the Arkansas plant, FDA documents show. No FDA inspector returned to the plant.

Rockline recalled wipes from its China plant in 2010 because they did not have enough preservative and listed no expiration date. FDA has the authority to inspect overseas operations if their product comes to the U.S., but no inspection has been performed, according to agency records.

In March 2011, the company again found bacterial contamination on wipes made at the Arkansas plant.

The company notified the agency it was recalling 18 brands of wipes, including Wal-Mart's Equate and Roundy's Baby Wipes, because of possible contamination with Enterobacter gergoviae, a bacterium experts said is associated with fecal matter.

In response to the recall, the FDA arrived at the Springdale plant last June, its first visit since 2006. The plant had added an in-house lab and treatment of its tap water.

An FDA report noted that company leaders thought sanitation problems were to blame for the current contamination. The inspector also found the plant was not investigating complaints and making basic errors in testing.

Zeppos said all the problems have been addressed.

Rockline has not alerted the public about the latest recall. Zeppos said the FDA told the company a news release was not necessary.

Kim McCarthy, a Kenosha County mother of a baby girl, unknowingly used two of the products on the current recall list. She said the recall should have been widely publicized.

"Contamination doesn't seem like something I should have to worry about, but obviously there is cause for concern," she said. "We give these companies our business, and we trust they are putting out a safe product."

Ben Poston of the Journal Sentinel staff contributed to this report.

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