Merck Receives FDA Warning Letter

West Point, PA (Apr. 28)-Merck and Company received a Warning Letter from the US Food and Drug Administration about its West Point, Pennsylvania, facility. FDA cited Merck's failure to address concerns raised in an earlier Form 483 about the facility.

The original Form 483 followed and inspection between November 26, 2007 and January 17, 2008. It included almost 50 observations, which identified failures to comply with current good manufacturing practices (CGMPs) in regards to licensed biological vaccine products, bulk drug substances, and drug components. Products involved in the inspection included "Liquid PedvaxHIB," "RECOMBIVAX HB," "ProQuad," "Gardasil," "VAQTA," and "COMVAX." CGMP violations included noncompliance with Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act, 21 CFR Parts 210 and 211, and the company’s biologics license application.

The Warning Letter listed observations cited in the Form 483 that FDA felt were not properly addressed by Merck in its Feb. 15, 2008 response. Stating the response lacked specific details, FDA requested that Merck President Richard T. Clark and other senior management meet with FDA officials to discuss the company’s plans to correct the cited violations. FDA also stated in the Warning Letter that it “encourage[s] frequent interactions between your technical staff and FDA in an effort to help Merck move forward with corrective actions as rapidly as possible.”

FDA stated in a document posted on its website that “the deficiencies noted in the inspection of Merck’s West Point, PA, manufacturing facility are not expected to affect the availability of the firm’s licensed vaccines.” FDA also stated that these violations do not indicate that Merck’s vaccines are unsafe. 

Download the FDA Warning Letter at http://www.fda.gov/foi/warning_letters/s6756c.pdf.