FDA has expressed serious concerns over the ethylene oxide used during sterilisation which aimed to bring down microbial load in the same batch of baby powder produced in 2007
Maharashtra’s Food & Drug Administration (FDA) has cancelled Johnson & Johnson India’s licence to manufacture cosmetics at its facility in Mulund, a Mumbai suburb. The action relates to a a few batches of baby powder produced in 2007, the shelf life of which ended in July 2010. FDA has expressed concern over use of ethylene oxide for sterilisation to bring down the microbial load.
An FDA investigation revealed that before release of these batches, the company did not conduct the mandatory test to ensure absence of traces of ethylene oxide, a carcinogenic substance. Since it was used in a product meant for infants, FDA observed, it was more objectionable. 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. The move has come at a time when an FIR against one of J&J’s subsidiaries has been lodged for supply of faulty hip joints.
J&J has two company-owned facilities in India — at Mulund and Baddi in Himachal Pradesh. At Mulund, the company manufactures J&J Baby Powder, Band-Aid adhesive bandages and Stayfree sanitary napkins. It produces other products at its Baddi unit. The company also uses third-party manufacturers for production, but the Mulund facility, set up in 1959, is a large one and also its oldest.
Confirming the cancellation, FDA Commissioner Mahesh Zagde said 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.
A J&J spokesman confirmed the company had received the FDA order, which pertained to cosmetic products only, and the company 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. FDA raised concern about ethylene oxide treatment, which was not included as part of the manufacturing process submitted to FDA. This method is widely used for medical devices around the world. 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.”
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