FDA orders Merck to fix vaccine plant problems
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 report at Google News
- see the warning letter
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By Randy Crawford | Posted 10:43pm | May 2, 2008
From- Randy Crawford, 3701 Second St. #10, Coralville, Iowa 52241, (319)400-2837, rancrawfo@hotmail.com & randycrawford52241@hotmail.com
>>>> re-May 1, 2008 "FDA Orders Merck to Fix Vaccine Plant Problems" from www.fiercebioresearcher.com >>>>> I don't know what "manufacturing problems" the Merck vaccine plant in West Point, Pennsylvania has allegedly experienced. I do know that in the last 3 years I have had dozens and dozens of doses of Merck MMR vaccine (along with many doses of ProQuad, Varivax, and Zostavax). Using myself as a human guinea pig to find new ways to alleviate autoimmune disease [via vaccine-based immunodistraction], I have had no bad side effects from any of these numerous doses, and I can say from personal experience as a human subject that in my experience the vaccines have been entirely helpful and zero percent deleterious. If anything, vaccines need to be more widely used to alleviate suffering from autoimmune disease.
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