When reporting an Adverse Event to the Food and Drug Administration (FDA) the best method is to utilize the FDA Adverse Event Reporting System (FAERS). FAERS is a database that contains adverse event reports, product quality complaints that led to an adverse event, and medication error reports1. All FAERS reports are easily accessible to the public.  

FAERS is utilized to look for safety concerns of a product and evaluate the manufacturer’s compliance. If a safety concern is identified through the event reporting system additional evaluation for the product is completed. The FDA can take regulatory actions to ensure the safety and effectiveness of the product to protect overall public health.  

Consumers, manufacturers, and healthcare professionals can easily submit a report to FAERS. if a manufacturer receives a report from a consumer or healthcare provider, they are required to transfer the report to the FDA for submission. All adverse event reporting is completed through electronic submissions. The FAERS data has limitations on the factors that can influence whether an even or error occurred with the product. Some factors include the time the product has been marketed, the publicity of the event, and the recurrence of an event.  

All adverse event reports from 1968 to the present can be easily acquired through the FAERS public dashboard1. A user can view the summary of adverse event reports and search based on their product of interest within any timeframe since 1968. If you or your company needs assistance with submissions of adverse events or any other aspects of FAERS, EMMA International is here to help. Contact us by phone at 248-987-4497 or by email at info@emmainternational.com.  

1FDA (June 2018) FDA’s Adverse Event Reporting System (FAERS), retrieved on June 27, 2022, from https://www.fda.gov/drugs/surveillance/questions-and-answers-fdas-adverse-event-reporting-system-faers 

Sarah Koehler

Sarah Koehler

Sarah is a Quality Engineer at EMMA International. She has experience in quality assurance, change management, laboratory controls, and process/equipment validation within the pharmaceutical and medical device industry. Sarah has earned a Bachelor of Science in Chemical Engineering from Western Michigan University.

More Resources

Change Management And Control

Change Management And Control

One of the biggest and most important aspects of quality management is a system to monitor changes and how they impact the product. Change management is an approach for changing processes or products in a way which adheres to regulatory standards by ensuring stability and consistency throughout processes. It applies across all changes within a process and throughout an entire products life cycle.
Aseptic Technique and Gowning

Aseptic Technique and Gowning

One of the most common techniques to prevent contamination of products and reduce quality impacts in the pharmaceutical industry is called aseptic gowning. Humans are the biggest sources of microbial contamination in cleanroom environments and therefore proper gowning procedures are essential to ensuring product quality. Proper training, education, hygiene, qualification, and authorization must be put in place and be required for entry to all clean room environments...
Importance of Pharmaceutical GMP

Importance of Pharmaceutical GMP

Having high quality standards is vital to any organization but is even more essential in the pharmaceutical industry. Practices that are governed by these standards are commonly called Good Manufacturing Practices (GMP) and ensure consistent and controlled production of products. These practices govern all aspects and procedures within production and provide documented proof that procedures are consistently followed during the manufacturing processes every time products are made. They are designed to minimize risks throughout the manufacturing process that are not able to be eliminated in final product testing so that pharmaceuticals are safe for use...

Ready to learn more about working with us?

Pin It on Pinterest

Share This