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FDA Warns Vaccine Maker About Plant Conditions

July 5, 2006
The Food and Drug Administration has sent a warning letter to vaccine manufacturer Sanofi Pasteur about problems at its Swiftwater, Pennsylvania, manufacturing plant.

The letter says FDA inspections, carried out in April, observed a number of conditions that could lead to contaminated drugs.

"During the inspection, FDA investigators documented significant deviations from current good manufacturing practices (CGMP) in the manufacture of licensed biological products and Fluzone monovalent concentrate batches," the letter stated.

Among the problems observed by inspectors were a failure to keep equipment and supplies used in work on or otherwise exposed to any potentially pathogenic agent separated from equipment and supplies used in the manufacture of products to the extent necessary to prevent cross-contamination; failure to establish a system for maintaining equipment to control aseptic conditions; failure to follow appropriate written procedures to prevent microbial contamination of drug products purporting to be sterile; and failure of the quality control unit to ensure that errors are investigated.

The FDA inspectors said they found 11 Fluzone monovalent concentrate lots manufactured between February 2006 and April 2006 failed sterility tests. The lots have subsequently been destroyed.

The inspection was carried out after the company reported contamination of some drug lots the previous month.

The FDA said its inspection uncovered deficiencies in the way in which the company monitored conditions at the plant. On a number of points, the letter took issue with the company’s response to issues raised in the inspection, categorizing it in some cases as "unacceptable."

The pharmaceutical company specializes in the production of vaccines. Sanofi Pasteur produces vaccines protecting against 20 bacterial and viral diseases, including pertussis, diphtheria, typhoid fever, poliomyelitis, influenza and mumps.

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