Merck warned on vaccine plant problems

Last week, we heard the warning would be coming. And here it is. The FDA has given Merck 15 days to decide how to fix manufacturing problems at its main vaccine plant in West Point, PA, according to a warning letter dated April 30. The plant hasn't been adhering to manufacturing rules, the FDA stated; agency inspectors found "significant objectionable conditions" during repeated visits to the plant between November and January.

According to the letter, Merck officials didn't thoroughly investigate when vaccine batches failed to meet specifications, even if those batches had been distributed. Some drug components were tainted, and the plant lacked proper procedures and safeguards to ensure purity, the letter said. "We have reviewed the warning letter and are committed to addressing all of the FDA's concerns," a company spokeswoman told the Associated Press.

The plant makes children's vaccines, including PedvaxHIB for Haemophilus influenza type B and ProQuad against measles, mumps, rubella, and chicken pox. It also makes Merck's cervical cancer protectant, Gardisil. Last year, the plant recalled 1.2 million doses of the H. influenza shot because of a sterility problem.

- read the AP story
- see the FDA warning letter
- check out the Los Angeles Times article
- get the FDA's FAQ about this warning letter

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