FDA cites nearly 50 areas of concern at Merck vaccine plant

MONTGOMERY COUNTY, Pa. According to a report in The Philadelphia Inquirer, the Food and Drug Administration have documented unwanted “fibers” in the stoppers of vaccine vials at Merck’s vaccine plant. The agency also found instances of contaminated children’s vaccines and complaints that weren’t always investigated.

Inspectors from the FDA spent 30 days at the plant between November and January of this year and cited 49 areas of concern, including a failure to follow good management practices.

John McCubbins, Merck’s head of global vaccine manufacturing and West Point operations, disputed that assessment. He maintained that the division’s employment had kept pace with vaccine production. He stressed that no contamination was found in finished vaccines and that Merck was addressing all the problems.

McCubbins stressed that Merck’s own technicians—not FDA inspectors—had detected and reported most of the problems, which were found in the manufacturing process, not in vaccines themselves.

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 plant continues to operate, and the FDA has not ordered Merck to stop production or to recall any products.