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FDA issues warning letter to GlaxoSmithKline’s API plant in Ireland

2:27 AM MDT | April 2, 2014 | Deepti Ramesh

The US FDA issued a warning letter on 18 March to the active pharmaceutical ingredient (API) manufacturing facility of GlaxoSmithKline (GSK; London) located at Carrigaline in the county of Cork, Ireland, for violations of cGMP. An FDA inspection from 18–23 October 2013 at the Carrigaline facility identified deviations from cGMP for the manufacture of APIs, FDA says. The warning letter was published in the FDA web site on 1 April. The FDA has conducted a detailed review of GSK's response, but it lacks sufficient corrective actions, FDA says. The violations...

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