Viewing the right FDA Warning Letter is helpful, analyzing 100K+ enforcement documents is powerful


Dive into the most complete database of FDA Warning Letters and global enforcement documents. Built for experts by experts, Redica Systems’ platforms help you turn raw data into Quality and Regulatory Intelligence that reduces compliance risk for leading pharma and medtech companies.

This demo will teach you how to:

  • Search by agency, source, GxP, industry, inspection reason, and more
  • Locate FDA Warning Letters by date, company, FDA office, or subject
  • Learn about your investigator with comparison metrics, trends, and citation lists

Using Redica Systems


Redica Systems is a Quality and Regulatory Intelligence (QRI) platform. Designed with a deep understanding of the life sciences compliance landscape, it goes beyond basic data retrieval and offers deeper intelligence.

Redica Systems is also the largest database of FDA enforcement documents in the world other than the FDA itself. In addition to FDA 483s, Redica Systems also provides:

  • Warning Letters
  • 483Rs
  • EIRs
  • Investigator Profiles
  • Organization Profiles
  • Site Profiles

For more info, see our How It Works page.

In addition to FDA documents, Redica Systems also contains a growing number of documents from other important agencies around the world, like EMA, MHRA, Health Canada, and others.

One of the key advantages of Redica Systems is its robust data structuring, enrichment, and trend analysis capabilities. The platform doesn’t just present you with raw data. With the help of AI/ML, natural language processing, and human experts, Redica Systems presents you with important signals tailored to your needs, without the noise.

By leveraging advanced analytics and visualization tools, you can identify patterns, spot trends, and have a comprehensive understanding of quality compliance issues. Redica Systems also provides a unique window into every FDA investigator and the latest agency inspection trends across different types of inspections.

This way, you get valuable insights into the preferences, focus areas, and tendencies of FDA investigators. Understanding their approach can help you better prepare for inspections and address compliance gaps proactively.

How do we do it?  Our data comes from a unique blend of the Freedom of Information Act (FOIA) and web crawling of thousands of data sources.

Our Unmatched Data Set


Redica Systems’ unmatched data set contains:

  • >15,000 individual data sources
  • >200 Agencies and Standards bodies
  • Industry coverage includes: Human Drugs, Biologics, Medical Devices & IVD, Combination Products, Animal Health, and Food
  • GxP coverage includes: GLP, GMP, GCP, GMP for IMP, GVP, and GDP
  • >4,500 Inspector Profiles
  • >300,000 Site and Organization Profiles
  • >100k regulatory documents – 483s, Warning Letters, Untitled Letters, Certificates of Non-Conformance, Regulations, Guidance, etc



Bringing everything together


The Redica ID. It resolves all permutations of a particular site, organization, product, or person, into one comprehensive entity. Not only does that clear up confusion about the various combinations, but it also empowers clear linkages between a site that manufactures APIs and the organizations that use that site in their supply chains, as one example.

No more confusion over the vast number of permutations of a single organization or site’s name. Just one, clean, clear record.