R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

Revamping Supplier Quality: A Case Study

About R&Q's Case Studies: We hope this Supplier Quality Remediation 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 on supplier quality remediation? Contact us.


Challenge

The FDA found that not following your procedure is a problem.

A multibillion dollar client had a supplier quality process that was not being executed, and was not aligned to regulations (2CF820.50). Suppliers were not being audited at the prescribed regularity, some suppliers rated as low risk were making high risk parts, and others supplied product that did not meet current specifications. The results of an FDA inspection resulted in a Warning Letter that ultimately required third party audit certification. The organization had to react by proposing a plan to halt distribution of two product lines in order to focus on a permanent and comprehensive systemic solution.

Who’s watching your MedWatching?

Last year, FDA received almost one million adverse event reports from manufacturers1. Needless to say, the Office of Surveillance and Biometrics has been very busy, and so have manufacturers.

RQS Feature Article - Successfully Addressing Warning Letters

Regulatory and Quality Solutions is featured in another publication this week! Our President, Maria Fagan, has written an article focused on the top five tips on how to successfully address FDA warning letters. The article is featured in MedCity News and can be found here. FDA warning letters are not to be taken lightly, and the careful handling of them is critical to ensuring your business can move foward to produce safe and effective product. The article provides five great bullet-points of advice on putting your company on the right track with the FDA

Stay out of Frying Pans and Fires!

Quick note today as a training seminar came through my inbox.

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