GSK Biologicals Gets 483 for Persistent Mold Problem
GSK Biological’s Belgium plants continue to have mold issues that led to a fresh Form 483 for the facilities.
The agency first cited vaccine production plants in Rixensart and Wavre, Belgium, in 2012 for poor prevention of mold in the manufacturing area. FDA visited the facilities again in September and October and did not find much improvement.
Since the 2012 inspection, there were 190 mold deviations that caused four batches to be rejected, according to the Form 483 with 20 observations.
GSK conceded in 2012 that leaks in one of the buildings could contribute to the mold issues and would upgrade the water systems impacted by the leaks.
However, leaks in various manufacturing buildings continue. Significant leaks were documented during the filling manufacturing area that could allow for the growth of molds, the FDA said.
The agency said it found 118 manufacturing equipment and tank leaks during various vaccine manufacturing processes such as aseptic processing that could result in contamination.
GSK said it responded to the FDA and is addressing the concerns.
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