Deviations and CAPA

DEVIATIONS AND CAPA With lean work forces, FDA-regulated companies may find themselves with a backlog of deviations to be investigated and CAPAs to be resolved. Faster resolution using outsourcing results in less business, technical, patient, and regulatory risk. Globiox can take the pressure off and help the company to resolve its problems and meet its

High frequency of CAPA related observations in warning letters

Globiox proactively monitors FDA inspection trends by reviewing and analyzing the contents of the Warning Letters. A current trend we detected is the high frequency of observations related to Corrective and Preventive Actions (CAPA) in Warning Letters. Out of 43 Warning Letters issued to Medical Device companies (since March 22, 2013), 29 have contained observations relating

FDA 483: Does your business contain critical errors?

In the aftermath of an FDA site inspection resulting in unsatisfactory findings, the company in question faces a difficult situation that must be addressed quickly to avoid serious consequences. If not properly addressed, negative observations made during an FDA visit can ultimately result in suspended operations, bad press, scrupulous monitoring of operations, recall of products,