FDA suspends licence of Johnson & Johnson

Niticentral Staff | Apr 29, 2013 

  FDA suspends license of Johnson & JohnsonThe Maharashtra Food and Drug Administration (FDA), the apex body for food and drug products in the State, has reportedly suspended the licence of Johnson & Johnson, the multinational healthcare and consumer products major, to manufacture cosmetic products at their Mulund plant.

As per reports, the order was issued in a case dating back to 2007 when residues of carcinogenic substances were found in 15 batches of Johnson & Johnson baby powder. And later it was found out that the residue was found because that the talcum powder was sterilised by ethylene oxide which in is carcinogenic and irritant.

As per a report in The New Indian Express, Kamlesh B Shende, FDA joint commissioner (drugs), said: “There were unacceptable levels of ethylene oxide, which is a trigger for cancer. Ethylene oxide was being used to bring down microbial load in the powder by sterilisation. But it was found that there was ethylene oxide residue in the talcum powder, which is primarily used on infants. In light of this, we have suspended the licence.”

The spokesperson of Johnson & Johnson was quoted in the report saying, “The FDA raised concerns about following ethylene oxide treatment, which was not included as part of the manufacturing process submitted to the FDA.”

As per the reports, the order will become effective from 24 June.

(With inputs from agencies)


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