India court allows J&J to resume production at plant ordered closed 3 months ago

Johnson & Johnson ($JNJ), which has been battling a host of problems tied to its consumer healthcare operations, is back in the baby powder business in Mumbai, India. A plant that was ordered closed by authorities there three months ago has been allowed to resume production.

A high court in Bombay overruled an order from the state Food and Drug Administration that had yanked J&J's license for the plant, The Times of India reports. The company ran into trouble when it was learned that years earlier it had released 15 batches of baby powder that had been sterilized with the potential carcinogenic ethylene oxide but did not check for its residue. The company said there were no consumer complaints or adverse events reported and that it later tested three batches of the powder and found nothing of concern. But that didn't stop the Maharashtra FDA from ordering it to halt production at the plant, leaving 250 employees with nothing to do.

J&J appealed the order. The court on Thursday sent the issue back to the FDA with the judges asking "who will compensate them for the closure?" if they win their legal challenge, The Times of India reported.

It is one positive note in what has been a tough year for its consumer health operations. The company earlier this month recalled three lots, or about 200,000 bottles, of its concentrated Motrin infants' drops after plastic particles were detected in the API. In May, regulators in South Korea launched a probe after J&J's Janssen unit released some Children's Tylenol products that contained excessive levels of acetaminophen, then reportedly waited a month to acknowledge the mistake.

The issues are not new for J&J, however. Its McNeil Consumer Healthcare unit in 2011 signed a consent decree with the FDA promising to get on top of quality after years of recalls tied to problems at its OTC plant in Fort Washington, PA. It has spent $100 million to upgrade the facility after having to recall tens of millions of consumer products, including Tylenol and Motrin products, because of quality shortfall.

- read the Times of India story

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