Real-time enforcement analytics across FDA, EMA, Health Canada, and MHRA
Worldwide Vendor Intelligence
Search any pharma / biotech company to see all enforcement history, warning letters, and risk data across FDA, EMA, Health Canada & MHRA.
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Total Inspections
All jurisdictions · 2019–2026
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FDA Inspections
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EudraGMDP Records
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Health Canada
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UK MHRA GMDP
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WHO WHOPIR
PE
Peru DIGEMID
Global Site Coverage
Manufacturing & inspection sites across all jurisdictions
Inspection Classifications Over Time
Top Cited Regulations
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SitesSite Profile
Lonza Biologics, Visp
FEI: 3012345678 · Lonza Group AG · Switzerland
CMOSterileBiologics
Risk Score
72High
→ from 58 last year
Inspection Timeline
2024 OAI7 observations
Mar 4–12 · Lead: Investigator J. Martinez
2023 VAI5 observations
Jun 18–24 · Lead: Investigator R. Chen
2022 VAI3 observations
Sep 7–11 · Lead: Investigator R. Chen
2021 NAI0 observations
Feb 15–17 · Lead: Investigator K. Park
Top Cited Regulations
211.1924×
Investigation of discrepancies
211.683×
Automatic equipment
211.1602×
Laboratory controls
Linked Documents
Form 483
March 2024
Warning Letter
May 2024
Form 483
June 2023
EIR
April 2024
Investigator Profiles
FDA investigator patterns, observation focus, and assignment history
JM
J. Martinez
FDA · San Francisco District
87
Inspections
18%
OAI Rate
4.2
Avg Obs
2017
Active Since
Observation Focus
Data Integrity34%
Laboratory Controls24%
CAPA18%
Cleaning Validation12%
Equipment Qualification8%
Other4%
Recent Inspections
Lonza, Visp
Mar 2024
OAI
Samsung Biologics
Jan 2024
VAI
Catalent, Indiana
Nov 2023
VAI
Fujifilm Diosynth
Aug 2023
NAI
Trend Analytics
CFR citation heatmap, category trends, NLP insights, and benchmarking
Most Commonly Cited Regulations (2019–2025)
CFR Citation Breakdown
Click any row to open heatmap deep dive
Regulation
2022
2023
2024
2025
Trend
Vendor Type Risk Benchmarks
Average observations, data integrity & sterile rates by vendor type — click to drill down
CFR Citation Heatmap
Top 20 regulations × year — click any cell or row label for deep dive
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High
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Deep Dive
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By Severity (AI-classified)
Year-by-Year
By Vendor Type
By Country
Top Co-Citations
Violation Category Trends (AI-classified)
15 violation categories over time
Category Summary
Click any row to filter Document Library by this category
Category
2022
2023
2024
2025
YoY
NC Reports
0
EMA GMP Non-Compliance
Unique Sites
0
Countries Covered
0
Issuing Authorities
0
Batch Recalls
0
GMP Certs Withdrawn
0
CEPs Withdrawn
0
Supply Prohibited
0
QP Failures
0
EU Regulation Citation Heatmap
Top cited EU Directives & Regulations by year — click any row to drill down
Low
High
Affected Products Analysis
Products most frequently appearing in non-compliance reports — supply chain risk signals
Site Country vs Issuing Authority
Cross-border inspection patterns — which authorities inspect which countries
Operation Type Breakdown
Which manufacturing operations correlate most with non-compliance?
Companies with Non-Compliance
Sites with the most NC reports — click to drill down
Supplier Type Trends
Document volume by vendor type over time (excl. generic Pharmaceutical Manufacturer)
Supplier Type Breakdown
Supplier Type
2022
2023
2024
2025
YoY
Sterile vs Non-Sterile Trends
Enforcement activity split by sterile / non-sterile manufacturing over time
SterileNon-Sterile
Sterile Summary
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Non-Sterile Summary
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NC Inspections
0
Health Canada AI Data
Unique Establishments
0
Domestic / Foreign
0 / 0
Currently Licensed Rate
0%
Avg Obs / Inspection
0
% With Critical
0%
Repeat Observation Rate
0%
Top Province
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NC Inspection Volume Over Time
Stacked by inspection origin — click any bar to drill down
Observation Severity Composition
100% stacked by severity level per quarter
Observation Category Trends
Top categories by quarter — click to drill down
FDR Citation Heatmap
Part C, Division 2 — Food and Drug Regulations
Repeat Offender Analysis
Top establishments by inspection count — click to drill down
Activity Breakdown
Licensed activities at non-compliant establishments
Geographic Distribution
Provinces (domestic) and countries (foreign) — click to drill down
Warning Letters
0
FDA AI-Parsed Data
Active Companies
0
Open / Unresolved
0
Closed Out
0
Avg Obs / Letter
0
% Critical
0%
Repeat Violation Rate
0%
Data Integrity Rate
0%
Sterile Flag Rate
0%
Enforcement Volume Timeline
Monthly Warning Letter volume with average critical severity overlay
CFR Citation Heatmap
Top 20 cited regulations by year — click to drill down
Violation Category Trends
Top violation categories by quarter — stacked area
Observation Severity Over Time
Critical / Major / Minor proportion per quarter
Enforcement Lifecycle
Funnel from issued to closeout + response time by category
Risk Flag Prevalence
Data Integrity, Sterile, Repeat — % of letters per quarter
Repeat Violation Deep Dive
Top repeat offender companies — click to drill down
Issuing Office Analysis
Warning Letter volume and severity by FDA office
Risk Flag Co-occurrence
How often flags appear together — highest risk combinations
Response Time by Violation Category
Median days from issue to response — do some categories take longer?
Total 483 Inspections
0
5-Year Window
Unique Companies
0
Total Observations
0
OAI Classifications
0
VAI Classifications
0
Avg Obs / Inspection
0
% Critical
0%
Data Integrity Rate
0%
Repeat Obs Rate
0%
Median Duration
0 days
Volume & Classification Over Time
Quarterly 483 volume with NAI/VAI/OAI classification breakdown
Severity Composition
Critical / Major / Minor observation proportions per quarter
21 CFR Citation Heatmap
Top 20 cited regulations by year — click to drill down
Observation Category Trends
Top categories by quarter — stacked area
Establishment Type Analysis
Inspections by establishment type — avg observations per inspection
Geographic Distribution
Top countries and US states by inspection volume
Investigator Analytics
Top 15 investigators by inspection count — avg observations overlay
Repeat Observation Tracking
Top repeat offender companies + repeat rate trend over time
Inspection Duration Analysis
Avg inspection duration by quarter + breakdown by establishment type
Risk Flag Prevalence
Data Integrity, Sterile, Repeat — % of inspections per quarter
Document Library
483Mar 2025
Lonza Biologics Visp
7 observations · FDA
WLJan 2025
Samsung Biologics Incheon
Warning Letter · FDA
483Nov 2024
Catalent Bloomington
4 observations · FDA
EIRSep 2024
Fujifilm Diosynth RTP
Establishment Inspection Report
GMPJul 2024
Boehringer Biberach
GMP Certificate · EMA
Form 483 Lonza Biologics
March 2025 · PDF Document
PDF viewer would render here
Parsed Observations
AI-extracted from document
121 CFR 211.192
CRITICALInvestigation
Failure to thoroughly review any unexplained discrepancy, whether or not the batch has been already distributed…
221 CFR 211.68
MAJOREquipment
Automatic, mechanical, and electronic equipment is not routinely calibrated, inspected, or checked according to a written program…
321 CFR 211.160
MODERATELab Controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards…
Regulatory Policy Intelligence
Proactive alerts based on enforcement trends auto-generated for your sites
AI-POWERED
HIGH PRIORITYGenerated 2 hours ago
Supply Chain Release Testing Trending Up 23%
FDA has increased citations for 21 CFR 211.84 (testing of incoming raw materials) by 23% in the last 6 months, particularly at biologics CMOs. This directly impacts Biogen's contract manufacturing network.
21 CFR 211.68 citations at sterile biologics facilities have increased 15% year-over-year. FDA investigators are focusing on computerised system validation and audit trails.
CFR: 211.68, 11.10Affected sites: All sterile CMOs
INFORMATIONALGenerated 3 days ago
EMA New Annex 1 Enforcement Patterns Emerging
EudraGMDP non-compliance statements referencing revised Annex 1 (sterile manufacturing) have appeared for the first time. Early signal monitor closely.
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UK
MHRA
UK inspection outcomes, deficiency reports, Yellow Card data
MHRA data view inspection reports and deficiency data from gov.uk
JP
PMDA (Japan)
GMP inspection reports translated from Japanese
PMDA data view Japanese GMP inspection reports with translation layer
