Quality Control Failures at Johnson & Johnson

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In fall 1982 seven people in the Chicago suddenly died after taking Extra-Strength Tylenol capsules manufactured by McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson. The product was laced with cyanide. At the time Johnson & Johnson claimed no responsibility of the poisoning tablets but it did recall all its products from shelves of drug stores and supermarkets and replaced the capsule drug with tablets. The company came very openly and declared that they would never sell unsafe products to its customer. Johnson & Johnson at the time was praised in the media for the way they handled the recall and the company became a model for how to handle an ethical crisis. If we see the recent challenges that are happening to Johnson &…show more content…
3. In January 2011, it was announced that Johnson & Johnson will need to do the covering out up to $1 billion for lawsuits concerning its subsidiary DePuy Orthopaedics. The metal-on-metal hip implants were found to shed tiny metal particles into a patient’s bloodstream over time. The main accusation is that DePuy is manufacturing a defective product and did not do enough to warn patients and doctors of problems with the implant and careless in designing, manufacturing and selling the product. A recent FDA regulators report is saying that Johnson & Johnson “still hasn't solved all the problems at the Pennsylvania plant largely responsible for a huge recall of children's medicine earlier this year.” Plant operations have been suspended as Johnson & Johnson performed in depth review of its manufacturing processes. However, finance reports from FDA investigators on recent inspection conducted in the plans have revealed again problems on manufacture control. The main failures are in establishing control procedures that monitor the output and validate the performance of the manufacturing processes. There is failure to thoroughly review any impenetrable discrepancy and failure of a batch or any of its components. Another major problem is lack of record keeping allowing data to be reviewed at least annually to evaluate the quality
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