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.
Wondering what would improve your device company’s CAPA performance? We have answers from an exclusive, new FDAnews survey of devicemakers: Medical Device Manufacturer CAPA Benchmarking Survey.
For the first time ever, FDAnews surveyed 229 medical devicemakers to reveal how the industry is approaching CAPA investigations, what the industry is experiencing in terms of enforcement, and what best practices exist to better manage CAPA investigations.
Get an unprecedented look inside CAPA programs throughout the industry as well as benchmarks and insights to help you structure your CAPA system for maximum effectiveness and justify your positions with upper management. Order this report today!