Integra Gets Form 483 After Audit Reveals CAPA, GMP Deviations

Plainsboro, N.J.-based Integra Lifesciences landed a seven-observation Form 483 detailing problems found with the company’s corrective and prevention action (CAPA) procedures and GMP violations. Interim reports, required under the company’s CAPA procedures, were not filed, and extension requests were not in evidence during the June 12 to July 30 inspection by the FDA’s New Jersey district office. The same problem was cited following Integra’s last inspection, the Form 483 states.
The GMP Letter