Thursday December 12, 2019

Glaxo's Cork facility gets FDA warning over manufacturing

The US Food and Drug Administration (FDA) has warned GlaxoSmithKline that its Cork manufacturing plant has breached manufacturing regulations.

2nd April, 2014
FDA said it may refuse admission of articles manufactured at the Cork facility into the US.

The US Food and Drug Administration (FDA) has warned GlaxoSmithKline that its Cork manufacturing plant has breached manufacturing regulations.

In a warning letter posted online yesterday, the FDA told GlaxoSmithKline that it found significant violations of current good manufacturing practice (cGMP) regulations at the active pharmaceutical ingredient (API) manufacturing facility in Carrigaline in Co Cork.

The violations were found during an FDA inspection last October, the agency letter said. The agency said these deviations cause...

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