A March 2011 US Food and Drug Administration (FDA) inspection of a GlaxoSmithKline (GSK) plant in Worthing, UK found failings with microbiological contamination and laboratory control procedures.
The FDA said: “A media fill conducted during January 2011 resulted in two contaminated units. Your firm attributed the failures to stopper bags left inside the class 100 area for a long period of time. There is inadequate information available to support your conclusion.”
Information about microorganisms recovered from the stopper bags and the sterility test conducted are lacking, the FDA said. Also, according to the FDA, GSK planned to use the media fill data to extend “sterility holding times for product contact components, without the approval of [the] quality unit”.
Failings at the laboratory were also raised. “Please review all the out of specification investigations for product within expiration date to determine if the investigation procedures were properly followed”, the FDA said.
The Worthing site, which the FDA calls SmithKline Beecham, began operations in 1960 and produced commercial batches of amoxycillin, clavulanic acid and formulated Augmentin. GSK says Augmentin, an antibiotic, still accounts for 70 per cent of the site’s business and is exported to 140 countries.
As well as problems with microbiological contamination and laboratory control procedures the FDA also found failings in the visual inspection. A vial with a cracked neck, missing stopper, high or low weight, and a foreign body are all critical defects but excluded from the inspection programme.
“This test will only show that the technician is capable of detecting a missing cap, but it does not show that the technician is capable of detecting other critical defects”, the FDA said.