June 24, 2014 — The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to ID Biomedical Corporation of Quebec, a subsidiary unit of GlaxoSmithKline, after inspectors found violations of quality-control standars in the manufacturing of Flulaval, an influenza vaccine.
The primary concern was a failure to take appropriate steps to prevent microbial contamination of drugs, in violation of federal law requiring all sterile products to have some level of sterility and bioburden testing during validation. The warnings stem from inspections between March 31 and April 9, 2014.
The FDA was concerned that controls for the purified water system at the facility were inadequate to prevent contamination. Records show that employees discovered bacteria in the water system but failed to set a schedule to regularly disinfect the water system.
For example, on March 7, 2012, the water-borne bacteria Achromobacter xylosoxidans was found in the purified water system in the facility. Reports dating back to 2011 identified this bacteria and others in product contamination issues.
Some problems were specific to the Flulaval flu vaccine, which contains an inactivated virus incapable of causing the flu. However, the FDA found documents indicating that ID Biomedical was unable to determine if the flu virus had actually been inactivated, which could put patients at risk.
The FDA asked ID Biomedical and GSK to perform a “comprehensive and global assessment of all its manufacturing operations” to ensure medicines conform to FDA requirements. According to the agency:
“The deficiencies … are an indication of your quality control unit not fulfilling its responsibility to assure the identity, strength, quality, and purity of your licensed biological drug product and intermediates.”
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