FDA Warns GSK Vaccine Plant Over Contamination Problems

GlaxoSmithKline’s vaccine plant in Canada received an FDA warning for a bevy of quality violations such as failing to prevent contamination in its manufacturing processes and water system.
The warning letter stems from a March inspection of GSK Biologicals’ Quebec City facility, which is used to produce influenza vaccines.

Investigators found the manufacturing process controls failed to prevent product contamination. “Throughout 2013-2014 the process continued to generate out of specification results (OOS) results for bioburden and endotoxin even after several corrective and preventive actions were implemented,” according to the June 12 to GSK Biologicals’ subsidiary ID Biomedical.

So far this year, the plant has rejected 20 product lots because they showed bacterial growth. In 2011, the company rejected 24 lots due to OOS endotoxin results. Another eight lots were rejected back in 2012 due to OOS results for bioburden and endotoxin.

Investigators also found GSK was unable to prevent contamination of its purified water system. For instance, there is no set schedule for disinfecting the system, according to the letter. GSK disinfected the system twice in 2011, five times in 2012, four times in 2013 and only once this year to date.

GSK’s initial response to the Form 483 issued after the inspection contained insufficient detail, noted the FDA, which has asked the drugmaker to meet to discuss a more robust response.

GSK said it is making progress addressing the agency’s concerns. The drugmaker added that it is working with Canadian health regulators to meet its vaccine supply commitments for the 2014-15 flu season, and plans to provide between 28 and 33 million vaccine doses to the U.S. for the next flu season.

GSK Biologicals is the latest subsidiary of the British drugmaker to get an FDA warning letter. SmithKline Beecham received a warning earlier this year for contamination of drug ingredients produced at its Cork, Ireland, plant.