Latest FDA 483 report shows spread of J&J quality woes

Johnson & Johnson continues its manufacturing quality meltdown with the announcement of unsatisfactory FDA inspection results from a Lancaster, PA, plant, just 70 miles west of the idled Fort Washington plant at the center of the Tylenol recalls.

The facility produces OTC medicines in a joint venture with Merck in which the pair develops and market prescription medications from Merck as over-the-counter drugs. Products include heartburn relievers Mylanta and Pepcid as well as the drug Imodium.

J&J spokeswoman Bonnie Jacobs, who has been on watch throughout much of J&J's recent spate of inspection observation reports, warning letters and product recalls, cited the now familiar statement that the company takes the issues seriously and is fully committed to addressing FDA concerns as rapidly as possible.

The Lancaster plant action is more evidence of a systemic quality failure at the drug giant.  

- read a CNN Money report
- here's more

Launch Readiness

Optimize cross-functional collaboration and engage with key stakeholders for the successful launch of a product

Join the Launch Readiness for Medical Affairs & Communications Teams Summit to learn best practices in taking a structured approach to enhance medical affairs activities surrounding a launch and increase knowledge and communication with thought leaders.