Merck's Manufacturing Problems at Gardasil Factory May be Easing, but
There Are Still Problems
Date Published: Monday, August 4th, 2008
Not too long ago, Merck received a Food & Drug Administration (FDA) warning letter citing good manufacturing practice violations at its vaccine operations in West Point, Pennsylvania following an inspection that cited 49 Form 483 observations. Among the products made at the plant is the cervical cancer vaccine, Gardasil. During its second-quarter earnings call, Merck reported that the FDA closed out the warning letter that claimed bulk drug substances for many of Merck's vaccines were adulterated.
"On July 10, Merck received a letter from the FDA closing out its recent inspection at the West Point manufacturing facility. As a result, any filed sBLAs which were held up due to the inspection can now move through the agency's normal review and approval process," Merck CEO Dick Clark said. "Concerning supplements, we have at least two supplements with the FDA concerning Gardasil and they will move through the process," he said. Merck states the supplements are for expanded labeling for Gardasil and that it will respond to an FDA complete response letter for the use of the vaccine in women 27–45 years of age.