FDA warns Merck to fix vaccine plant problems

April 30, 2008 8:28:10 AM PDT
The Food and Drug Administration is warning drugmaker Merck & Co. to fix problems at Merck's main vaccine plant in Pennsylvania.The agency on Wednesday released a warning letter sent to Merck's chief executive that says FDA inspectors found their manufacturing rules are not being followed at the plant in West Point, Pa.

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 can take actions including suspending the plant's manufacturing license and seizing products.