FDA Fails to Conduct Safety Checks on Makers of Disposable Wipes
On 14.01.12, In Legal Industry, by Blake Houser
Half a decade ago, a letter was sent by whistleblowers to the federal regulators, warning them about contaminated baby wipes streaming out of a factory in Arkansas, with its Wisconsin-based owner not telling the government and the public.
Two employees of that factory wrote to the Food and Drug Administration, saying that Rockline Industries knew about the contamination but proceeded to ship the harmful wipes to “the hands and bodies of thousands of Americans.”
The employees even warned that officials at the plant use the code phrase “Judy Life to the front desk,” which they use to broadcast over the factory’s PA system in the event of a surprise inspection.
Two weeks after receiving the letter, an FDA investigator arrived at the plant site unannounced and discovered various problems, which include defective product testing and poor sanitation. Company records also show customers have been complaining about presence of foreign objects, like razor blades and dead bugs in the wipes.
Later that month, Rockline, which manufactures wipes for a number of retailers under various brand names, announced a nationwide recall of twenty brands of baby wipes that may be contaminated but they say posed minimal risk.
When the FDA test results came back, it showed the suspect wipes were indeed contaminated with Burkholderia cepacia, a type of bacteria that pose a health risk to any individual with compromised immune system.
Experts told the media that the bacteria level were thousands of times higher than FDA guidelines, enough to make anyone sick, even those that enjoy healthy immune systems.
However, the FDA did not take any enforcement action.
A review of the case files of the FDA show lax manufacturing practices by the wipes makers, the FDA’s poor oversight, and failure by everyone to notify the public of the health risks.