Most warning letters are issued by the FDA for one of two reasons. Either the company's response to a preceding form 483 was deemed inadequate, or the observations made during the inspection were serious enough to warrant a supporting warning letter.
For the company on the receiving end of a warning letter, determining the proper corrective actions to take typically starts by dissecting the details of the issues cited. Depending on the contents of a particular warning letter, this analysis can be challenging. To help you orient your review, we've highlighted five questions that can help you understand the which corrective actions you will need to take.Continue Reading
The new Medical Devices Regulation (EU-MDR) brings a number of significant changes, putting pressure on all impacted parties to closely examine the Regulation, assess the impact it will have on their own organization, and implement compliant processes and procedures accordingly.
Since MDR’s release in 2017, many regulatory experts have published and circulated resources aimed at helping companies understand the new rules and adjust their organizations accordingly. While many of these resources are extremely useful, we set out to offer a tangible, step-by-step guide that can be adapted to fit the needs of many companies.Continue Reading