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The findings are detailed in an unpublished 21-page FDA report obtained by The Inquirer under the federal Freedom of Information Act.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.
The report cites cases where bulk lots of PEDVAX and ProQuad were contaminated. Unwanted "fibers" were found on the vial stoppers of MMR, the measles, mumps and rubella vaccine, among others. They were caused by "lesser quality" supplies from a vendor, the FDA report said.
The report noted defective vials had to be rejected twice to be discarded, and that one internal quality investigation went on for more than a year.
Several experts said no single finding was horrendous but that the overall pattern was troubling. "It's the sum of many small things that puts the whole operation in question," said consultant Wheelwright.
-could these "unknown fibers" be morgellons disease i have spoke about frequently on my blog?
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FDA report shows problems at Merck vaccine plant | Philadelphia Inquirer | 04/24/2008