Vaccine Manufacturing Plant Receives FDA Warning
The FDA gave a regulatory warning to a vaccine manufacturer, involving multiple quality-control observations made after a review of the manufacturing plant in Pennsylvania.
The company, Merck, makers of the blockbuster selling human papilloma virus vaccine Gardasil. Also makers of a hepatitis A, two hepatitis B vaccines and the makers of Vioxx. According to news reports, the regulatory warning should not hamper the vaccine makers ability to sell the currently marketed product.
According to a number of news reports, the FDA's warning letter sent to Merck & Co. mentioned "significant deviations from current good manufacturing practice. . . in the manufacture of licensed biological vaccine products, bulk drug substances, and drug components" at the plant based in Pennsylvania.
The letter was dated the 28th of April and is based on the FDA inspection covering November 2007 through January 2008. According to news reports, the FDA noted that certain lots of pediatric vaccines were recalled as a precautionary measure in December 2007, with production suspended, with distribution not expected to resume until the fourth quarter of 2008. One of the vaccines recalled were those chemically manufactured to prevent disease caused by Haemophilus influenza type B in infants.
