The move comes after the Administration carried out an investigation on some batches of baby powder produced in 2007, the shelf life of which ended in July 2010, that revealed J&J did not conduct mandatory tests to ensure the absence of traces of ethylene oxide before the release of those certain batches.
FDA Commissioner Mahesh Zagde says the company had carried out sterilisation of 15 batches (of 160,000 retail containers) of baby powder by using ethylene oxide, against the normal practice of steam sterilisation.
And that since it was used in a product meant for infants, the FDA observed, it was more objectionable.
"We have not suspended the licence, we have cancelled it. The company cannot manufacture the Johnson baby powder at this stage,'' adds K.B. Shende, Joint Commissioner (Drug), Maharashtra FDA.
The cancellation order was issued on March 30, though J&J has been given 90 days (up to June) to plead its case before the state government, if the company wants.
J&J has opportunity to plead its case
A company spokesman confirmed it had received the FDA order, which pertained to cosmetic products only, and that J&J would continue to manufacture non-cosmetic products at the same site. “The matter in question as cited by the FDA order relates to a limited number of batches produced in 2007."
"This was followed as an exception and all internal safety protocols were followed to ensure that safety of the consumer was not compromised. In addition, we have ascertained that there were no complaints or unexpected/undesirable effects reported concerning any of the batches in question.”
J&J has two company-owned facilities in India — at Mulund and Baddi in Himachal Pradesh. It also uses third-party manufacturers for production, but the Mulund facility, set up in 1959, is the largest and also the oldest.