Reply #52: FDA warns Merck to fix vaccine plant problems [View All]

[AnneD]

TRENTON, N.J. — The Food and Drug Administration has ordered drugmaker Merck & Co. to correct manufacturing deficiencies at its main vaccine plant.

The agency on Wednesday 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., just outside Philadelphia, which makes a number of children's vaccines.

The nine-page letter refers to what the FDA calls "significant objectionable conditions" found during repeated inspections at the plant between November and January.

Merck officials didn't thoroughly investigate when vaccine batches inexplicably failed to meet specifications, even if batches had been distributed, according to the heavily redacted letter.

The FDA also said that some drug components were tainted, and that the plant didn't have written procedures, tests or other laboratory controls to ensure "strength, quality, and purity" of products.

http://www.chron.com/disp/story.mpl/ap/business/5742774.html

Last year they had to recall 1.5 mill doses of hib b. We have met the enemy and they is us.