About R&Q's Case Studies: We hope this case study is valuable to you. Here are our currently available case studies. Subscribing to our blog is the best way to know when future case studies are available.
Questions? Contact us.
The FDA found problems you didn't think were there.
A multibillion dollar client has been marketing product for years with insufficient attention to corrective actions. An analysis of the CAPA records showed 62 open CAPA’s at inception, with an average age of 1.3 years each. The client believed that their process was adequate and therefore did not apply the necessary resources to find a solution. Additional lack of response to FDA Warning Letters resulted in a consent decree, which included the need to improve the CAPA process.