Integra Sees Positive Inspection Following 2011 Warning Letter

Integra LifeSciences had a positive inspection of its Plainsboro, N.J., facility last month, demonstrating successful remediation of citations from a late-2011 FDA warning letter. The July 16 to Aug. 14 inspection “focused primarily on the issues raised in the warning letter and in previous inspections of the Plainsboro facility,” according to a recent SEC filing. “The FDA found that the company had addressed the issues … and it issued no other inspectional observations,” the company adds.
The GMP Letter