Merck Warned About Plant Issues

Merck & Co. has received a warning letter from the FDA concerning issues with manufacturing standards at its West Point Pennsylvania facility. The facility in question manufactures vaccines and was cited by the FDA for numerous deviations in its laboratory procedures. The FDA noted that Merck’s lab procedures were not scientifically sound when it came to assessing the “strength, quality and purity” of products manufactured at the West Point, Pa. facility. Merck has failed to evaluate the stability of certain vaccines such as measles, mumps, and rubella over a number of years.
Merck’s latest issues comes in the wake of Congressional testimony slamming the FDA and fellow pharmaceutical giant Baxter for its failure to safeguard its heparin supply. The tainted heparin, imported from China, has been linked to 81 deaths in the USA.
Recently, the FDA has come under increasing fire from Congress as the safety and quality of pharmaceuticals has been criticized.