US
FDA 483 Observations Database
Inspection observation data from the U.S. Food & Drug Administration covering pharmaceutical manufacturing facilities nationwide.
iPharmaAI · Global Regulatory Coverage
Global Inspection
Global Inspection
Intelligence Platform
Track FDA 483 Observations, EMA & MHRA compliance certificates, and non‑compliance deficiency reports — all in one unified platform.
3
Regulatory Regions
FDA
EMA
MHRA
Agencies Covered
15,396
483 Observations
24,787
EUDRA Records
1,702
UK MHRA Records
AI-Powered
483 Observation Summaries
GMP & Non-GMP Compliance
Tracked Certification Status
3
Regulatory Regions
FDA · EMA · MHRA
Agencies Covered
15,396
483 Observations
24,787
EUDRA Records
1,702
UK MHRA Records
AI‑Powered
483 Observation Summaries
GMP & Non‑GMP
Certificate Types Tracked
Region 01 — United States
FDA
Multi‑Filter Search
Filter 483 observations by Organization, Company, FEI Number, Type of Establishment, System, Investigator, Year, Country and Keyword Search.
AI‑Generated Summaries
Every 483 observation is paired with an AI-generated plain-language summary so compliance teams can extract insights in seconds - not hours.
Full Observation Text
Access the complete, unedited text of every FDA 483 observation exactly as issued during inspection.
Trend & Pattern Analysis
Spot recurring patterns across Observations by cGMP System, Type of Establishment, and Geographic Location.
Region 02 — European Union
EU
EMA EudraGMDP Database
GMP and Non-GMP Compliance Certificates alongside Non-Compliance Deficiency reports from the European Medicines Agency and EU member state authorities.
EMA . EU
Member States
Member States
GMP Compliance Certificates
Certificates confirming an inspected manufacturing site meets EU GMP requirements, issued post‑inspection.
Non‑GMP Compliance Certificates
Compliance certificates issued for facilities operating under Non‑GMP frameworks within the EMA network.
Non‑Compliance Deficiency Reports
Reports issued where inspected sites were found to be non-compliant with EMA standards, detailing specific deficiencies identified.
Region 03 — United Kingdom
UK
MHRA GMDP Database
Post-Brexit MHRA inspection outcomes including GMP and Non-GMP Compliance Certificates and
Non-Compliance Deficiency reports for UK-regulated sites.
MHRA
GMP Compliance Certificates
MHRA‑issued GMP compliance certificates for UK‑based and internationally inspected manufacturing sites.
Non‑GMP Compliance Certificates
Certificates issued by MHRA for sites operating outside standard GMP scope, under UK‑specific requirements.
Platform Capabilities
Built for Regulatory Affairs & Compliance Teams
iPharmaAI's Global Inspection Database doesn't just store data — it transforms it into regulatory intelligence. From pre-inspection prep to vendor qualification, every feature is designed for how real RA team’s work.
Cross‑region filtering
Search and compare inspection outcomes across the USA, EU, and UK from a single unified interface.
Document downloads
Download original compliance certificates and deficiency reports directly from the platform.
Regularly updated
Database continuously refreshed with the latest inspection outcomes and certificate statuses as they are published.
Audit‑ready data
Structured, traceable data designed to support internal compliance reviews and regulatory audit preparation.
AI‑powered insights
Automated summaries and trend analysis help teams cut through large volumes of inspection data efficiently.
Vendor selection support
Assess a vendor’s complete regulatory history, including FDA 483s, GMP Compliance Certificates & Deficiencies Reports and FDA, EMA, MHRA actions to identify recurring risks, enabling informed supplier qualification decisions.
© 2026 iPharmaAI.