South Korea eyeing criminal charges over J&J plant failures
pharmafile | May 17, 2013 | News story | Manufacturing and Production |Â Â J&J, JJ, Janssen, Korea, MFDSÂ
The chief executive of Johnson & Johnson’s South Korean subsidiary could be facing criminal charges over quality lapses at a manufacturing facility, according to local news reports.
Kim Oak-yeon could face a jail term of up to three years if found guilty of knowingly allowing over-strength batches of liquid paediatric Tylenol (acetaminophen) product to be released into the South Korean supply chain, says a Korea Times report.
Earlier this month the country’s Ministry of Food and Drug Safety (MFDS) suspended production at the Hwaseong plant run by J&J’s Janssen subsidiary, and ordered a nationwide recall after the discovering some bottles had 20%-50% more active ingredient than was on the label, which could have exposed children to potentially serious side effects such as liver damage.
An MFDS spokesman told reporters earlier this week that Janssen became aware of the problem in March but failed to notify the regulator for a month, during which time it distributed around 38,000 bottles of the 100ml and 500ml Children’s Tylenol Suspension product, which is indicated for use in children aged from 4 months to 12 years.
The quality failure has been blamed on an equipment malfunction which led to some elements of the production process being carried out manually. The regulator is also concerned that Janssen did not notify it of the process change, in violation of Good Manufacturing Practice (GMP) regulations.
Janssen has previously said that the defective products accounted for less than one third of a percent of the total number of bottles distributed.
“We will co-operate with the authorities and make every effort to regain the trust of consumers, patients, medical experts and the government,” said Oak-yeon in a statement.
The MFDS – which until last year was known as the Korea Food and Drug Administration – has recently undergone a major restructuring exercise aimed at strengthening its ability to protect consumers from adulterated and substandard products.
Phil Taylor
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