When you take into consideration that elements of the manufacture and servicing of medical devices make up 24% of the controls set in place by FDA’s 21 CFR 820 Quality System Requirements, it should come as no surprise that recalls related to these same controls make up 24% of all recalls since 2010. As we have done with both design and software controls before it, our analysis of production controls seeks to explore the specific recalls, hazardous situations, trends, and possible mitigations related to each of the root causes associated with production control related recalls.
