Catalent says it has resolved issues FDA noted at North Carolina site

The Catalent Pharma Solutions facility in Morrisville, NC, where the company manufactures inhalation products, was written up with a half-dozen observations during a routine visit back in March, according to the Form 483 that the FDA posted publicly recently. Among the issues that concerned inspectors was the way the company was handling some batch production records, its failure to find out if some noted deviations had affected products and the fact that the company was not keeping pace with the stability testing schedule, testing some products past the appropriate date. Chris Halling, Catalent's senior manager for global communications and European marketing, said in an emailed statement that the company responded immediately and "The FDA later recommended approval of the Morrisville facility for the manufacturing and testing of the products concerned." Form 483 (PDF) | More

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