Health officials have revoked Johnson & Johnson's license to make cosmetics at a plant outside Mumbai after they discovered the company had used an unauthorized process for sterilizing its baby powder.
J&J said in a statement on Friday that it is in "ongoing discussions" with Indian regulators.
"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.
An investigation by the Maharashtra Food and Drug Administration revealed that J&J, at its plant in Mulund, had used ethylene oxide - a substance used to produce industrial chemicals and to sterilize medical equipment - to kill bacteria in its baby powder and had not conducted mandatory tests to make sure there were no remaining traces in the powder.
According to the U.S. Department of Labor, acute exposure to ethylene oxide can cause lung damage, nausea, vomiting and cancer.
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