Compliance Series 2: Focus on Quality Not Compliance
The Office of Pharmaceutical Quality (OPQ), launched in 2015, will be used to carry out the FDA’s long term plan to establish a uniform quality program for drug manufacturers. The […]
Category: Compliance
Compliance Series 1: Managing Compliance Risks with EAM
In our previous blog series, we briefly explored the growing enforcement of the FDA. From 2007 to 2012, the number of warning letters given by the FDA drastically increased as […]
Top 5 Measurable Costs of a Warning Letter
Top 5 Measurable Costs of a Warning Letter In part one of this two part blog series, we laid out the top 5 immeasurable costs to an FDA warning letter; […]
Top 5 Immeasurable Costs of a Warning Letter
A Warning Letter Form FDA 483 “Inspectional Observations,” is a form used by the FDA to communicate concerns and document observations made by the FDA representative(s) during the inspection of […]