FDA warns Merck to fix vaccine plant problems

By LINDA A. JOHNSON AP Business Writer

TRENTON, N.J. (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.