April 30, 2008
Federal inspectors documented unwanted “fibers” on the stoppers of vaccine vials at Merck & Co. Inc.’s vast vaccine plant in Montgomery County.
They also found instances of contaminated children’s vaccines and complaints that were not always investigated at the West Point plant.
Inspectors from the U.S. Food and Drug Administration spent 30 days at the plant between November and January and cited 49 areas of concern, including a failure to follow good manufacturing practices.
The findings are detailed in an unpublished 21-page FDA report obtained by The Inquirer under the federal Freedom of Information Act.
Independent experts who reviewed the report say it documents serious concerns in one of the country’s premier vaccine plants. They suggested the problems could be a symptom of Merck’s cost cutting in the face of rapid growth of its vaccine business.