Hopestone FDA Inspection & Form 483 Analyzer

Primary company and facility

Company search

Enter at least three characters, then select an FDA applicant name.

No company is saved in this browser.

Registered establishment

Registered establishment details will populate after a company is selected.

Date range

Start date

End date

Inspection classification

NAI VAI OAI Classification unavailable

Inspection location

Document availability

Analysis options

Include observation analysis Include potential repeat observations Include investigator analysis Include FDA office or branch analysis Include regulatory follow-up analysis Include peer benchmarking

The included inspection records load automatically. Regional data retrieval and local inspection analysis are available under Inspection History.

Analyze FDA inspection history, Form 483 observations, repeat findings, investigators, follow-up actions, and company performance.

Use the FDA inspection analyzer to research registered establishments, inspection history, citations, public records, investigators, regional activity, and integrated inspection intelligence.

About this tool

Open User's Guide (PDF)Instructions for company and facility selection, inspection analysis, citations, public records, investigators, the Analysis Brief, and FOIA requests.

Inspection classifications are based on finalized FDA inspection records when available.
Form 483 observations are not final FDA determinations of legal violations.
Form 483 and EIR availability may be incomplete.
Investigator and observation information may come from FDA-hosted or user-reviewed documents.
Analytical categories and AI-generated interpretations require knowledgeable user review.

Select a company and reporting period, then choose Analyze Inspections.

Start date	End date	Company	Establishment	FEI	City	State / region	Country	Location	Program / project area	Classification	Record type	Form 483	Observations	Lead investigator	FDA office / branch	Warning Letter	EIR	Public links
No inspection records loaded.

REGIONAL COMPARISON

Nearby FDA Inspection Activity

Select a radius and lookback period, then retrieve FDA inspection data. Results are filtered by FDA Product Type, deduplicated by inspection ID, sorted by distance, and displayed automatically.

Comparison center: Select a registered establishment.

Distance

Custom distance

Lookback

Product type

Choose the distance and click Get FDA Data.

Live FDA records are not selected automatically. Review distance and public-record status before selecting records.

Verified address-distance0

Estimated city-distance0

Unknown distance0

Establishments shown0

VAI0

OAI0

Form 483 not located0

EIR missing0

Select
Choose Get FDA Data to retrieve and display the regional comparison.

Click any column heading to sort. Click it again to reverse the order. Distance defaults to nearest first.

Public-record labels: “Download Form 483” means a PDF URL was verified. “Citations posted” means FDA indicates citation data, but the actual 483 PDF was not confirmed. “View FDA profile” opens the source record. FOIA may still be required.

COMPANY & SITE TRENDS

FDA Inspection Activity Timeline

Review inspection activity across the selected company and registered establishments. Markers show inspection date, classification, facility, and record type.

Run an inspection analysis to populate the company and site timeline.

SELECTED INSPECTION

Inspection Details

Inspection ID	Inspection end date	Project area	Product type	Classification	Additional details	Citations / Form 483 status	EIR-related information	FDA source

Inspection Citations Details

Select an inspection to retrieve citation details.

Inspection ID	Inspection end date	Program area	Act/CFR number	Short description	Long description

Citation descriptions reflect fields returned by FDA’s posted inspection-citations dataset. They may not represent the wording or complete set of citations in a final classification letter or Form 483.

No inspections selected

Track which inspection records are publicly available, user-provided, not located, or recommended for FOIA.

Select an inspection to review public-document availability and record source URLs, retrieval dates, and FOIA recommendations.

Inspection date	Establishment	FEI	Classification	Form 483	EIR	Firm response	FDA correspondence	Warning Letter	Recommended action	Actions
No inspection analysis loaded.

Enter a known investigator name to research that person’s publicly documented FDA history. No prospective local-candidate prediction is performed.

No investigator records are currently available for this analysis. Investigator names are not consistently included in FDA structured inspection data and normally require a publicly available Form 483, EIR, or another reviewed FDA record.

Potential local investigator candidates

Candidates are estimated from publicly documented office association, geography, relevant inspection history, and recency. FDA may assign personnel from another office or region.

Select a company and registered facility, then generate the candidate list.

Named Investigator Research

Enter the investigator’s name before running research. The analyzer will then search HHS and FDA public records for that specific person. No candidate list, geographic prediction, or broad personnel search runs while the name is blank. LinkedIn is not scraped automatically.

Enter a specific investigator name to enable focused public-record research.

Loaded FDA records searched0

Reviewed investigator names0

Directory connectorNot tested

Directory results0

Corroborated candidates0

Review named-investigator research results

Directory results are not saved until selected below. The research pipeline now uses FDA internal search, FDA-hosted warning-letter and inspection records, PDF text extraction, loaded inspection data, and role-context classification. Directory-only personnel remain separate from evidence-backed inspection history.

No automated results are available for review.

Select	Name	Title	Organization	Duty location	Qualification	Score	FDA public records	Documented inspections	Program support	Detail resolution	Detail status	Rationale
Run the automated search to populate this table.

Automated search criteria

Connector diagnostic

Background-job endpoint: /api/investigator-candidates/search using POST to start, GET to poll, and DELETE to cancel. When opened from the ZIP, the analyzer uses http://localhost:8787. The server should query permitted public sources, normalize results, and return source URLs and evidence classifications. The standalone HTML does not fabricate directory results when the server is unavailable.

Add or review directory-only candidate

Use this only when a public HHS/FDA directory result identifies a potentially relevant employee but no reviewed inspection record confirms inspection activity.

Name

Directory organization / office

Directory source URL or note

Candidate	Candidate classification	Historically associated office	Geographic relevance	Publicly documented inspections	Relevant product type and project areas	Earliest documented activity	Most recent documented activity	Source strength	Rationale
No candidate analysis generated.

Inspection history associated with the selected FDA office or branch. Observation trends will remain unavailable until supporting Form 483, EIR, or related records are located and reviewed.

Enter an FDA office or branch or use imported office data to generate this analysis.

INSPECTION INTELLIGENCE

Company, Site, Citation & Readiness Intelligence

Combine FDA inspection history, classifications, citation themes, public-record gaps, and preparation priorities into one integrated result.

OVERALL INSPECTION INTELLIGENCE

Overall Regulatory Intelligence Result

Generate one integrated analysis brief using inspection history, classification trajectory, FDA citations, reviewed observations, evidence coverage, public-record gaps, escalation signals, and readiness priorities.

Company / siteSelect and analyze a company.

Reporting periodNot available

Evidence includedNo inspection evidence loaded.

Run an inspection analysis, then generate the integrated analysis brief.

The analysis uses loaded inspection classifications and FDA citation records. Reviewed observations and linked actions are included when available, but are not required.

Run an inspection analysis to populate the guided inspection intelligence workflow.

Evidence coverage

Evidence area	Status	Available evidence	Limitation

Intelligence coverage score

Insufficient evidenceRun the analysis and review record gaps.

Historically observed focus areas

Missing evidence and recommended action

Select inspection records that should be included in a consolidated FOIA request.

Reviewed Citation & Observation Evidence Manually review, supplement, and export evidence associated with individual inspections.

Reviewed evidence supporting the overall inspection intelligence result.

Observation and citation trends will populate from publicly available or FOIA-obtained records that have been reviewed and associated with an inspection.

Select	Inspection date	Establishment	FEI	Observation	Citation	Primary category	Confidence	Review status	Actions
No observations entered.

FOIA request generation

Select an inspection after data integration to generate requests for a missing Form 483, EIR, response, correspondence, or related inspection record.

FDA Inspection & Form 483 Analyzer

Analyze FDA inspection history, Form 483 observations, repeat findings, investigators, follow-up actions, and company performance.

Inspection classifications by year

NAI, VAI, and OAI distribution

Inspections by establishment

Form 483 observations by category

Inspection activity by country

Company versus peer classification rates

Nearby FDA Inspection Activity

FDA Inspection Activity Timeline

Inspection Details

Inspection Details

Inspection Citations Details

Potential local investigator candidates

Named Investigator Research

Review named-investigator research results

Add or review directory-only candidate

Company, Site, Citation & Readiness Intelligence

Overall Regulatory Intelligence Result

Overall Inspection Intelligence

Evidence coverage

Intelligence coverage score

Historically observed focus areas

Missing evidence and recommended action

Analyze FDA inspection history, Form 483 observations, repeat findings, investigators, follow-up actions, and company performance.

Inspection classifications by year

NAI, VAI, and OAI distribution

Inspections by establishment

Form 483 observations by category

Inspection activity by country

Company versus peer classification rates

Nearby FDA Inspection Activity

FDA Inspection Activity Timeline

Inspection Details

Inspection Details

Inspection Citations Details

Company, Site, Citation & Readiness Intelligence

Overall Regulatory Intelligence Result

Overall Inspection Intelligence

Historically observed focus areas

Missing evidence and recommended action

Inspection record