FDA Reportedly Finds ‘Concerns’ at Merck Plant in Pennsylvania
A newspaper says federal inspectors are reporting 49 areas of concern at Merck & Co. Inc.’s vaccine plant in Montgomery County.
The Philadelphia Inquirer reports that it obtained an unpublished report on the findings of FDA inspectors who spent 30 days at Merck’s West Point plant between November and January.
The concerns range from failure to follow good management practices to unwanted fibers found on stoppers of vaccine vials and cases where bulk lots of vaccine were contaminated.
Merck executive John McCubbins says the company is addressing the problems. McCubbins heads Merck’s Global Vaccine Manufacturing and West Point operations. He says no contamination has been found in finished vaccines.
The FDA has not ordered the Whitehouse Station, N.J.-based company to stop production or recall any products.
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Information from: The Philadelphia Inquirer
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