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Pharma & Life Sciences Document

Regulatory submissions demand perfect data extraction.

FDA 483 Observations Data Extraction

Extract observations from FDA Form 483 inspection reports

No credit card required to get started.

13 Fields extracted
93%+ Accuracy rate
<30s Processing time

Regulatory document review slows submissions

Regulatory affairs teams manually extract data from clinical trial protocols and FDA correspondence. Compliance deadlines leave no room for error.

  • Complex regulatory document requirements
  • Strict submission timelines
  • Critical safety and efficacy data
  • Manual extraction delays submissions

Data we extract from fda 483 observations.

Structured output ready for your systems.

Company NameExtract the inspected company/facility name...
Facility AddressExtract the facility address...
FEI NumberExtract the FDA Establishment Identifier (FEI) num...
Inspection Start DateExtract the inspection start date. Return in YYYY-...
Inspection End DateExtract the inspection end date. Return in YYYY-MM...
Inspection TypeIdentify inspection type: Pre-Approval, Routine/Su...
Number of ObservationsCount the total number of observations...
ObservationsExtract all observations as JSON array with keys: ...
Data Integrity IssuesAre there data integrity related observations? Yes...
CGMP ViolationsAre there CGMP violations noted? Yes or No...
InvestigatorsList the FDA investigators/inspectors names...
Responsible PersonExtract the name of company responsible person who...
Products CoveredList products or product types covered by the insp...
1

Upload

Upload your fda 483 observations documents in PDF, image, or scanned format. Drag and drop or use our API.

2

Extract

Our AI identifies and extracts all 13 fields with 93%+ accuracy. No templates or training required.

3

Review

Review extracted data with confidence scores. Approve, edit, or flag items for human verification.

4

Export

Download as JSON, CSV, or Excel. Integrate via API or webhook to your existing systems.

Who uses fda 483 observations extraction?

Regulatory Affairs

Extract data for FDA submissions.

Clinical Operations

Process trial protocol documents.

Quality Assurance

Extract data from batch records.

Pharmacovigilance

Process adverse event reports.

Frequently asked questions.

Common questions about fda 483 observations extraction.

483s are critical inspection findings.

We extract observation number, description, and citations. Each finding becomes a trackable item.

We need to track remediation.

Extract findings as structured data for CAPA tracking systems.

Observations reference regulations.

CFR citations are extracted with each observation.

What about facility details?

Facility name, FEI number, inspection dates are captured.

Historical 483 analysis?

Process historical 483s for trend analysis and inspection prep.

Can we try it?

Yes. Sign up for evaluation credits and upload FDA 483s. No payment required.

"We were drowning in documents"

Our team processed hundreds of documents monthly by hand. Errors crept in, deadlines slipped, and skilled staff spent their time on data entry instead of strategic work.

Automated extraction changed everything. Same volume, processed in a fraction of the time. Our team finally focuses on what matters.

— Operations Director, Enterprise Company

Ready to automate fda 483 observations processing?

Processing 1,000+ documents monthly? Let's discuss your requirements.

No credit card required to get started.

P.S. The first 10 documents are on us. See for yourself.