J&J a big name in every household has been going through tough times. Recently, they recalled millions of over the counter medicines like Tylenol, Benedryl and Mortin due to the manufacturing issues at two facilities, one of which is closed. Now the third manufacturing plant located at Lancaster, PA has been under the scrutiny of FDA.
Repetitive Manufacturing Concerns
This is not the first time when J&J manufacturing plants are under scrutiny. Last year J&J has shut down a plant in Fort Washington, a Philadelphia suburb which is now linked to eight recalls of Tylenol and other nonprescription drugs for children and adults. FDA inspectors found thick dust, grime and contaminated ingredients at that plant.
The Lancaster plant is operated by a joint venture called Johnson & Johnson/Merck Consumer Pharmaceuticals Co. The factory manufactures products, including heartburn medicine Pepcid and Mylanta, and the Mylicon infant anti-gas drops.
Reaction of FDA
FDA spokeswoman Elaine Gansz Bobo said that they are still reviewing the report and cannot discuss the issues publicly until sensitive commercial information has been blacked out. That’s the agency’s standard practice.
J&J respond to the Inspection
In a statement, the joint venture said it “takes the issues raised by the agency seriously and is fully committed to addressing their...
concerns as rapidly as possible. We will provide a detailed response to the FDA and work diligently to address all observations.”
This looks like a chain reaction which started last year in September 2009 and looks like is not going to end. J&J is required to overhaul its quality system and get a handle on the extent of the problem. For a company which is one of the best medical companies in the world, not following Good Manufacturing Practices (GMP) is a major concern. There are only three plants that have been found in violations of FDA GMP, there is uncertainty if the problem persists in other plants too.