Criminal Charges on J&J in South Korea Tylenol Case

Criminal Charges on J&J in South Korea Tylenol Case

May 16th, 2013 // 2:33 pm @

Latest FDA and cGMP Compliance News

There is a new J&J cGMP manufacturing scandal in South Korea, and it is getting worse. Two weeks after J&J had to stop production on Children’s Tylenol syrup because some bottles had a higher concentration of active ingredient, regulators are bringing criminal charges against people in the Janssen division there. Also, production of five products will be banned in the next several months.

The Ministry of Food and Drug Safety already had demanded that Janssen recall/discard about 2 million bottles of Children’s Tylenol. Now the agency in South Korea plans to hold the company accountable for selling products that threaten public health. Larger amounts of acetaminophen can cause damage to the liver.

The South Korean regulator also has ordered that Children’s Tylenol Suspension production must be stopped until October. Also, Nizoral production was stopped for 4 months, Pariet acid reflux tablets also were banned for a month.

The ban on production does not surprise us. In early May, a spokesperson for the ministry stated that drugmakers usually have to stop producing medicines when cGMP problems are detected.

The problems seemed to start when employees at Janssen put Tylenol syrup manually into bottles. New automatic operations could not fill the bottles appropriately at the end of the manufacturing process.

This is just the latest cGMP manufacturing problem for J&J. The firm also is working on fixing a plant in Pennsylvania where there have been many recalls in recent years. J&J had to sign a consent decree with FDA on that matter.

As we have seen, serious cGMP problems can lead to warning letter, consent decrees, and even criminal charges in extreme cases. An upcoming Webinar of ours will detail how senior management can easily improve their company’s quality system with just a few hours of oversight each year.

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