With Enforcement Analytics, you can access deeper intelligence about inspection trends and investigator tendencies.

Our inspection intelligence gives you unique insights into every FDA investigator and the latest agency inspection trends across inspection types, including pre-approval inspections (PAIs), for-cause inspections, and routine inspections on all GxPs.

With more than 4,500 distinct Investigator Profiles containing data from proprietary research and quality system classification, Enforcement Analytics makes it easy to see how to prepare for your next inspection based on the expected investigator’s tendencies and hot-button items.

Continue reading to discover how a leading pharmaceutical company uses our data to always be prepared for agency inspections.

Challenge

A global pharmaceutical firm manages 10 FDA regulatory inspections per year across its 100 global sites. They relied on tribal knowledge and consultants for inspection preparation with limited visibility into the latest agency trends and hot-button issues.

They were often caught off-guard by the idiosyncrasies of specific FDA investigators.

Solution

For strategic planning, the client leverages our Annual Observation Trend Report to discover the latest trends in 483 Observations, providing a fact-based way to focus their planning efforts on the top-cited items.

For tactical planning, the client uses our Investigator Profiles to deep-dive into the specifics of each investigator, including their CV, their categorized observations and citation history, and how they benchmark against agency averages.

Impact

With access to recent and historic inspection and enforcement trends, plus knowing how investigators behave, the teams are able to prioritize their inspection preparation with precision and confidence.