Johnson & Johnson's plant licence revoked on quality concerns
04 May 2013
Health officials have revoked Johnson & Johnson's licence to make cosmetics at a plant in suburban Mumbai after the company was found to have used a dangerous and unauthorised process for sterilising baby powder.
Officials of the Maharashtra Food and Drug Administration have found that the maker of childcare products had used ethylene oxide - an additive in industrial chemicals used to sterilise medical equipment - to kill bacteria in its baby powder.
According to the FDA, the J&J plant at Mulund, near Mumbai, had been doing this without the mandatory tests to make sure there were no traces left in the powder.
The company, meanwhile, said in a statement on Friday that it is in "ongoing discussions" with regulators in India.
"We understand their concerns and are diligently working with them to resolve the issue," Peggy Ballman, a J&J spokeswoman, said in a statement, adding that there were no consumer complaints or adverse events reported due to its use of the process.
Exposure to ethylene oxide in extreme cases can cause lung damage, nausea, vomiting and even cancer, according to the US department of labor.
Ballman said the company is appealing the decision and the plant has not been shut down as yet.
She also said the sterilization process was used on a one-time basis on a limited amount of baby powder. Baby powder is made from corn or talc and is usually sterilized using steam, she said.
"For a brief time in 2007, we used an alternative sterilization process," she said.
She, however, did not explain as to why the alternative process was used, but said it is a "widely accepted and safe practice of sterilization used when making many medical devices and consumer products and leaves no harmful residue."
"However," she said, "the process was not registered with the local FDA and they viewed this step as out of compliance."
Quality problems are not new to J&J, whose consumer healthcare division has, over the past few years, recalled millions of bottles of over-the-counter products such as Motrin and children's Tylenol.
The revelations come at a time when Johnson & Johnson is seeking to rebuild its image as a trusted family brand.