Abstract
Background: Control of the quality of pharmaceutical and healthcare products in the market is mandatory to ensure the safety and efficacy of the delivered product to the final consumers. The United States Food and Drug Administration (FDA) is providing a continuous and comprehensive updated list for various healthcare issues including drug recalls. Methods: This study provides a multidimensional analysis using statistical process control (SPC) tools to evaluate the risk associated over a 3-year period (2016–2018). Results: The study showed a simple implementation of the combination of SPC tools, which demonstrated that the major contributors to recalls are microbiological quality issues, problems with product compositions, and packaging defects. Months that contributed by more than 60% of the total recalls were from May to August, November, and December. Conclusion: The general trend of drug recall rates is increasing yearly, which should be a warning signal for the regulatory agencies to take preventive measures to control and prevent excessive cases of recalls.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callMore From: Global Journal on Quality and Safety in Healthcare
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
