FDA cancels J&J’s licence manufacture cosmetics in Mulund, India

FDA cancels J&J’s licence to manufacture cosmetics in Mulund, India

11:36 AM, 29th April 2013
FDA cancels J&J’s licence to manufacture cosmetics in Mulund, India

MUMBAI, INDIA: 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 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 30 March, though J&J has been given 90 days (up to June) to plead its case before the state government, if the company wants.

Confirming the cancellation, Mahesh Zagde, Commissioner, FDA 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.

© Business Standard News

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