FDA to Inspect Vaccine Plant
USA Today; 9D
BioPort, the Michigan drug manufacturer that is the sole producer of an anthrax vaccine for the U.S. government, will submit documents to the Food and Drug Administration (FDA) intended to resolve some issues at its plant. The obstacles facing BioPort's inability to deliver the vaccine involve the plant's extensive manufacturing facility renovations made in order to produce the product. The FDA halted anthrax vaccine shipments in November 1999, after an eight-day inspection revealed potential problems at the plant. Problems identified ranged from improper or insufficient hand washing to failure to investigate adverse reactions reportedly associated with the vaccine. Once it receives the new documents, the FDA will review them and then conduct another inspection of BioPort's plant, before deciding whether or not to approve the company's request for a supplemental license, which is required when a drug manufacturing plant makes extensive renovations.