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Originally published November 9 2010

More Johnson & Johnson drug factories cited for terrible quality control

by David Gutierrez, staff writer

(NaturalNews) Only months after a massive recall of over-the-counter drugs due to quality control issues, Johnson & Johnson subsidiary McNeil has been cited by the FDA for similar problems at another factory.

The Lancaster, Pa., factory, which makes the gas and heartburn drugs Imodium, Mylanta and Pepcid, received a notice that inspections had found it in violation of 12 good manufacturing processes. Five of these violations had also been observed at a now-closed plant in Fort Washington that was responsible for a recent recall of foul-smelling cold and pain drugs that caused nausea and other side effects in consumers.

The Lancaster plant was cited for questionable lab procedures and quality controls and for failure to properly review unexplained manufacturing discrepancies, keep adequate maintenance records, document equipment malfunctions, follow up on consumer complaints. Consumer complaints included lack of effectiveness and mint-flavored Pepcid tablets found in a bottle of berry-flavored tablets.

"If this is going on in Johnson & Johnson plants that make over-the-counter drugs, is this indicative of what is going on in other parts of the company's business?" said former FDA staffer David Rosen, now a pharmaceutical compliance advisor.

But Johnson & Johnson's troubles may reflect more on the United States' drug regulatory system than on the practices of one company in particular.

"Although staffers have a hard time admitting it, the FDA really relies on the honor system," write Joe and Teresa Graedon in their book Best Choices From the People's Pharmacy.

"Inspectors are supposed to visit each drug manufacturing plant every two years, but the agency does not have the manpower or resources to accomplish this task. Consequently, several years may pass between visits. Shady operators may not be scrupulous about maintaining standards in the interim. Most worrisome of all, the FDA's random testing system is a joke. Although a few bottles are selected for analysis each year, they amount to a relative handful."

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