The Food and Drug Administration has ordered Merck & Co. to correct numerous manufacturing deficiencies at its main vaccine plant, the latest in a string of setbacks for the drug maker.
The FDA released a warning letter sent to Merck’s chief executive, Richard T. Clark, that states FDA inspectors determined manufacturing rules are not being followed at the plant in West Point, Pa. The plant, which recalled two vaccines in December over sterility problems, makes a number of children’s vaccines and four for adults.
The nine-page letter states FDA found “significant objectionable conditions” in the manufacture of vaccines and drug ingredients during repeated inspections from Nov. 26 to Jan. 17.
In a separate posting on its website, the agency said it issued the warning letter because Merck’s response to the FDA report sent after the inspections was “inadequate to address the serious deviations noted.”
According to the heavily redacted warning letter, Merck officials didn’t thoroughly investigate when vaccine batches inexplicably 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 laboratory controls to ensure “identity, strength, quality, and purity” of products.
However, the FDA said it “does not believe that the issues identified will affect the safety of the vaccines” made at West Point, or their availability.
“We’re committed to working with the FDA to ensure that all these issues are addressed to their full satisfaction,” said Merck spokeswoman Amy Rose, who added that the company does not distribute contaminated products.
“We are confident in the quality, effectiveness, and safety of our medicines and vaccines,” she said.
Rose said Merck would be submitting additional information to the FDA and discussing it in a meeting.
The warning letter gives Merck 15 days to tell the FDA how it will correct the violations. If Merck does not comply, the letter states the FDA can take actions including suspending or revoking the plant’s manufacturing license, seizing products.
