FDA483s.com is a free resource curated by Redica Systems, a data analytics platform helping life sciences companies improve their quality and stay on top of evolving regulations. Our proprietary processes transform one of the industry’s most complete data sets, aggregated from hundreds of health agencies and Freedom of Information Act (FOIA) sourcing, into meaningful answers and insights that reduce regulatory and compliance risk.
Please note: This website is not an official FDA website.
The main purpose of this site is to provide you with an easy-to-browse list of recently published FDA Form 483s, as well as share tips on best practices for avoiding 483s and generally reducing your compliance risk and improving your product quality.
Many of the FDA Form 483s listed on this site are available for instant purchase and download via the Redica Systems Document Store, along with many 483Rs and EIRs.