The Maharashtra government on Monday upheld the Food & Drug Administration (FDA) Commissioner’s decision to cancel Johnson & Johnson India’s licence to manufacture healthcare products from its facility in Mulund in suburban Mumbai. The FDA had cancelled the licence of J&J facility in March after it found that 15 batches of baby talcum powder manufactured at the Mulund plant were sterilised using ethylene oxide, a chemical that is widely believed to cause cancer, nausea, vomiting and is considered an irritant. The state FDA alleged that Johnson & Johnson did not register the process with it and failed to conduct mandatory tests to check for traces of ethylene oxide in the batches of talcum powder. In its appeal, Johnson & Johnson explained the circumstances under which it had to use ethylene oxide to sterilise the 15 batches – which comes to about 1,50,000 bottles of baby powder. According to the pharma giant, the 15 batches of powder had a pH level (the balance between alkalinity and acidity) that were higher than the prescribed limit set by the Bureau of Indian Standards. Therefore, the pH levels had to be brought down manually. The manual process involved human intervention which raised the susceptibility of the product to microbial content. The company has also admitted its failure to register the process with the local FDA and test the batches of powder to check for traces of ethylene oxide.
Posted on: Tue, 30 Jul 2013 11:53:38 +0000
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