The US Food and Drug Administration (FDA) issued a  warning letter to Merck and Co. (Whitehouse Station, NJ) on April 28, citing  numerous good manufacturing practice (GMP) violations at Merck’s vaccine production  operations in West Point, PA. The FDA also requested a meeting with senior  management at Merck to discuss the concerns cited in the warning letter.

  Vaccines  produced at the facility include the human papillomavirus vaccine Gardasil, and  the combination measles, mumps, rubella, and chicken pox vaccine ProQuad. 
 Specific  violations noted on the form include:

Validation  procedures on certain machines that were not representative of actual inspection  process;

Failure to  quarantine process intermediates associated with filter membranes that caused  foaming during filtration, which was associated with leaching into process  intermediates.

The FDA has stated that it has no reason to believe  the problems affected the safety of Merck’s vaccines. The agency also said that  the deficiencies would not affect the availability of the vaccines that are  manufactured at the West Point facility, with the exception of PedvaxHIB and  COMVAX, which were recalled in December 2007. 

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The FDA issued a warning letter to Merck and Co. (Whitehouse Station, NJ) on April 28, citing numerous GMP violations at Merck’s vaccine production operations in West Point, PA.