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In-depth Investigator Profiles
With more than 4,500 distinct FDA Investigator Profiles containing data from proprietary research and quality-system classification, you’ll easily see how to prepare for your inspector’s tendencies and hot-button items.
Unlock insights. Be better prepared.
Enforcement Analytics includes data sets such as:
Understand latest trends for 483 Observations on PAIs inspections – for Human Drugs, Biologics, and Medical Devices.
Base your audits and inspection planning activity on the most comprehensive and up-to-date inspection and enforcement trends and how you benchmark to the industry.
Leverage our cross-agency tables to link citations and non-conformances to your quality system categories.
Get the details you need with the full inspection and citation history for FDA investigators.
With the largest dataset of FDA 483s, Warning Letters, Health Canada Citations, EMA Critical Deficiencies, and more, you will have the most fact-based trends to power your inspection preparation program.
No longer “in the dark” when it comes to FDA inspection intelligence
Discover how a leading pharmaceutical company uses our data to always be prepared for agency inspections.
They were often caught off-guard by the idiosyncrasies of specific FDA inspectors.
“We need data-driven inspection intelligence. We don’t need anecdotes.”
For tactical planning, the client uses our Inspector Profiles to deep-dive into the specifics of each inspector, including their CV, their categorized observations and citation history, and how they benchmark against agency averages.
“This is truly remarkable. I have never seen analytics this granular for GCP.”
“We didn’t know what we didn’t know. Now, Redica helps us be more risk-based and to refine our agenda for audits.”
“Redica is an essential tool for our quality unit. I know our team will be fully prepared if an investigator arrives at our facility tomorrow. No guesswork here. With a simple search I can have enforcement trends by specific keywords presented quickly and clearly.”