FDA warns Merck to clean up violations at vaccine plant

By LINDA A. JOHNSON, AP Business Writer

(AP) -- The Food and Drug Administration is warning drugmaker Merck & Co. to fix problems at its main vaccine plant.

The agency on Wednesday released a warning letter sent to Merck's chief executive that says FDA inspectors determined manufacturing rules are not being followed at the plant in West Point, Pa., just outside Philadelphia.

The plant makes a number of popular children's vaccines, as well as Gardasil, which protects against cervical cancer. Last year, it recalled 1.2 million vaccine doses because of a sterility problem.

The nine-page warning letter gives Merck 15 days to tell the FDA how it will correct the violations. Otherwise, the FDA says it could suspend the plant's manufacturing license and seize products.

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Posted by sheber 04/30/08 20:27

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They recalled 1.2 million doses? How many people/children got their bad doses,(or the hot batches?) Our children are required to have more and more vaccinations every year. I'm surprised the human race made it this far without any vaccinations!