The FDA has issued a warning letter to Merck & Co. regarding several manufacturing deficiencies at its main vaccine plant in West Point, PA. The letter states that the FDA found "significant objectionable conditions" in the manufacture of vaccines and drug ingredients during repeated inspections from Nov. 26th to Jan. 17th. The FDA's warning letter was issued because Merck's response to the FDA report sent after the inspections was considered to be "inadequate to address the serious deviations noted."
   
The same plant recalled two vaccines in December, PedvaxHIB, to prevent Haemophilus influenza type B, and Comvax, a combination vaccine for Haemophilus B and hepatitis B, after sterility problems were discovered.
   
According to the letter, the company didn't thoroughly investigate when vaccine batches failed to meet specifications, even if batches had been distributed, and some combination measles-mumps-rubella shots that failed "visual inspection for critical defects" were distributed anyway. The letter also said the plant didn't have written procedures, tests or other lab controls to ensure "identity, strength, quality, and purity" of products. However, according to the FDA, the issues identified are not likely to affect the safety of the vaccines made at the facility or their availability.
   
"We're committed to working with the FDA to ensure that all these issues are addressed to their full satisfaction," said Amy Rose, a Merck spokeswoman. "We are confident in the quality, effectiveness and safety of our medicines and vaccines," she said. Merck will be submitting additional information to the FDA and will discuss the information in a meeting, which is requested in the warning letter.  

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