FDA Report Cites 49 Safety Issues At Merck Vaccine Plant

Between November of last year and this past January, the FDA “cited 49 areas of concern, including a failure to follow good manufacturing practices” at Merck & Co. Inc’s vaccine plant in Pennsylvania. A Merck spokesman says that most of the incidents were found and reported by Merck’s own employees, and that they occurred in the manufacturing process, not the vaccines themselves: “He stressed that no contamination was found in finished vaccines and that Merck was addressing all the problems.”

The Philadelphia Inquirer used the Freedom of Information Act to obtain a 21-page FDA report, then had experts review it for feedback:

FDA inspectors spent a total of 30 days at the West Point plant between Nov. 26, 2007, and Jan. 17, 2008. The agency could go on to issue a warning letter and take other actions if its concerns are not addressed. The FDA declined repeated requests to comment.
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. 
“FDA report shows problems at Merck vaccine plant” [Philly.com]
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