FDA Inspection Database: Complete Guide to Searching Inspection Records

An FDA inspection database is a searchable public repository containing records of all FDA facility inspections, Form 483 observations, warning letters, establishment inspection reports (EIRs), and classification outcomes. The database allows manufacturers, regulatory professionals, and the public to look up inspection history for any FDA-regulated facility.

Every year, FDA conducts over 18,000 domestic and international inspections across pharmaceutical, medical device, food, and biologics facilities. Each inspection generates documentation that becomes part of the public record, creating a massive repository of compliance intelligence that regulatory professionals must know how to navigate.

If you've ever needed to research a contract manufacturer's inspection history, benchmark your facility's compliance against industry standards, or understand why FDA classified a competitor's inspection as Official Action Indicated (OAI), mastering the FDA inspection database is essential.

In this guide, you'll learn:

• How to search the FDA inspection database and locate specific facility records
• What inspection classification outcomes mean and how they impact operations
• How to interpret Form 483 observations and warning letters in the database
• Advanced FDA inspection search techniques for competitive intelligence
• How to track FDA inspection history trends for risk assessment

What Is the FDA Inspection Database?

The FDA inspection database is the comprehensive, publicly accessible repository of all FDA facility inspection records, enforcement actions, and compliance documentation maintained by the U.S. Food and Drug Administration. The database includes inspection dates, outcomes, Form 483 observations, warning letters, establishment inspection reports, and classification determinations for every FDA-regulated facility.

Key characteristics of the FDA inspection database:

• Contains records from 1990 to present with monthly updates
• Covers all FDA-regulated industries (drugs, devices, biologics, food)
• Includes both domestic and foreign facility inspections
• Provides searchable access to 483s, warning letters, and EIRs
• Shows inspection classification outcomes (NAI, VAI, OAI)
• Links facilities to their FEI (FDA Establishment Identifier) numbers

The database serves multiple purposes: manufacturers use it for supplier due diligence, consultants analyze trends for client preparation, quality professionals benchmark compliance performance, and investors assess regulatory risk before acquisitions.

Understanding FDA Inspection Classifications

Every FDA inspection concludes with a classification that determines the regulatory consequences and required follow-up actions. The classification appears in the FDA inspection database typically within 90 days of the inspection completion.

The Three Classification Outcomes

NAI (No Action Indicated) classifications mean FDA found the facility in substantial compliance. The inspection database will show NAI for facilities where no Form 483 was issued or where observations were minor and corrected during the inspection.

VAI (Voluntary Action Indicated) is the most common classification in the FDA inspection database. It indicates FDA found violations documented on a Form 483, but the violations do not rise to the level requiring formal enforcement action. The facility is expected to correct these issues voluntarily.

OAI (Official Action Indicated) classifications appear in the FDA inspection database when violations are serious and regulatory action is warranted. Common reasons include:

• Data integrity failures
• Repeated violations from prior inspections
• Violations that created significant public health risk
• Fraudulent practices
• Failure to adequately respond to previous 483s

How Classifications Impact Operations

How to Search the FDA Inspection Database

The FDA inspection search process involves multiple databases and search methods depending on what information you need to find.

Primary FDA Inspection Database Portals

Step-by-Step FDA Inspection Lookup Process

Step 1: Identify the Facility FEI Number

Every FDA-regulated facility has a unique FDA Establishment Identifier (FEI) number. Finding this is critical for accurate FDA inspection database searches.

1. Visit the FDA Drug Establishment Current Registration Site (DECRS)
2. Search by company name or product
3. Note the 7-digit FEI number (format: 1000001 to 9999999)
4. Verify the facility address matches your target

Step 2: Search the Inspection Classification Database

1. Navigate to fda.gov Inspection Classification Database
2. Enter search criteria:

- FEI Number: Most precise search method

- Firm Name: Use partial names (e.g., "Pfizer" not "Pfizer Inc.")

- Date Range: Limit to relevant timeframe (default is 2 years)

- Classification: Filter by NAI, VAI, or OAI if researching specific outcomes

1. Review results showing:

- Inspection end date

- Classification (NAI/VAI/OAI)

- Product type inspected

- Posting date (when classification was finalized)

Step 3: Obtain the Form 483 (if issued)

FDA does not publish 483s in a searchable database, but you can obtain them:

1. Check if a warning letter was issued (warning letters include the 483)
2. Submit a FOIA request to FDA for the specific inspection 483
3. Check third-party databases (FDA only posts warning letters publicly)
4. Request directly from the facility if you have a business relationship

Step 4: Cross-Reference Warning Letters

If the inspection classification shows OAI:

1. Visit the FDA Warning Letters database
2. Search by firm name and approximate date (warning letters typically issue 3-6 months post-inspection)
3. Review the letter for:

- Specific violations cited

- FDA's required corrective actions

- Referenced 483 observations

- Regulatory consequences threatened

Step 5: Monitor for Updates

FDA inspection database records can be updated:

1. Set up automated searches if available
2. Re-check quarterly for new inspections
3. Monitor for re-inspection dates after VAI or OAI
4. Track whether OAI led to warning letter, consent decree, or import alert

Advanced FDA Inspection Search Techniques

Competitive Intelligence Searching

To benchmark your facility against competitors:

1. Identify competitor FEI numbers from their product registrations
2. Search inspection history for the past 5 years
3. Note frequency of inspections (indicates FDA scrutiny level)
4. Compare classification outcomes to industry averages
5. Review 483 observations for common compliance gaps

Supplier Due Diligence Searching

Before qualifying a contract manufacturer:

1. Obtain all FEI numbers (suppliers often have multiple facilities)
2. Search each FEI in the inspection classification database
3. Red flags in FDA inspection history:

- Any OAI in the past 3 years

- Multiple VAI classifications (indicates systemic issues)

- Gaps longer than 4 years between inspections (possible unreported changes)

- Warning letters unresolved after 12 months

1. Request supplier's response letters to any 483s found
2. Verify inspection coverage of the specific product types you need

Trend Analysis Searching

For regulatory intelligence and risk assessment:

1. Download inspection data for your facility type (drug, device, biologics)
2. Filter by date ranges (e.g., 2020-2025)
3. Calculate classification percentages by year
4. Identify emerging citation trends from warning letters
5. Compare domestic vs. foreign inspection outcomes
6. Track changes in inspection frequency by product type

Understanding Form 483 Observations in the Database

A Form 483 is the official FDA document listing observations of objectionable conditions found during an inspection. Not all inspections result in a 483, and receiving one does not automatically mean your classification will be VAI or OAI.

How 483s Relate to the FDA Inspection Database

483 Observation Categories You'll Find Referenced:

When you obtain a 483 through the inspection database search (via warning letter or FOIA):

1. Quality System Issues

- Inadequate investigation of complaints

- Insufficient validation protocols

- Deficient change control procedures

1. Data Integrity Violations

- Audit trail failures

- Backdating of records

- Deletion of original data

- Lack of electronic signature controls

1. Manufacturing Controls

- Inadequate cleaning validation

- Insufficient environmental monitoring

- Poor batch record documentation

- Equipment not properly maintained

1. Laboratory Controls

- Out-of-specification results not investigated

- Lack of method validation

- Inadequate reference standards

- Failure to follow written procedures

1. Facilities and Equipment

- Inadequate environmental controls

- Poor facility design leading to contamination risk

- Equipment not qualified

Reading 483 Observations: Severity Indicators

Not all 483 observations carry equal weight. FDA inspection database classification depends on:

FDA Warning Letters in the Inspection Database

Warning letters are official FDA enforcement actions that publicly document serious violations. They appear in the FDA inspection database as the final consequence of OAI-classified inspections.

Warning Letter Timeline After Inspection

What Warning Letters Reveal

When you find a warning letter through your FDA inspection database search, it contains:

1. Verbatim 483 observations: The complete list of violations
2. FDA's interpretation: Why these violations are serious
3. Regulatory citations: Specific CFR sections violated
4. Required corrections: What FDA demands the firm fix
5. Consequences threatened: Possible import alert, application holds, seizure, or injunction
6. Response deadline: Typically 15 business days

Warning Letter Search Strategy

Common warning letter violation themes in the FDA inspection database:

• Data integrity and electronic record violations (21 CFR Part 11)
• CGMP deviations (21 CFR 211 for drugs, 21 CFR 820 for devices)
• Failure to investigate complaints and product failures
• Inadequate cleaning validation
• Repeat violations from prior inspections

FDA Inspection Database Access Methods

Official FDA Portals

1. Inspection Classification Database

• Access: Direct web interface at fda.gov
• Update Frequency: Daily
• Coverage: 1990-present for drugs, devices, biologics
• Search Fields: FEI, firm name, city, state, classification, date range
• Export Options: Limited (copy-paste results)
• Best For: Quick lookup of specific facility classifications

2. Warning Letters Database

• Access: fda.gov/inspections-compliance-enforcement
• Update Frequency: Weekly
• Coverage: 1996-present across all FDA product centers
• Search Fields: Firm name, subject, issuing office, date
• Export Options: PDF download of individual letters
• Best For: Reading detailed violation descriptions and FDA requirements

3. FDA FOIA Electronic Reading Room

• Access: fda.gov/regulatory-information/freedom-information
• Update Frequency: As FOIA requests are fulfilled
• Coverage: Establishment Inspection Reports (EIRs), 483s, correspondence
• Search Fields: Limited; must know what to request
• Export Options: PDF documents
• Best For: Obtaining full inspection reports not otherwise public

4. Recalls Database

• Access: accessdata.fda.gov/scripts/ires/
• Coverage: Product recalls which may follow inspections
• Linkage: Can cross-reference FEI numbers to find related inspections
• Best For: Identifying post-inspection consequences

Third-Party FDA Inspection Databases

Interpreting FDA Inspection History Patterns

Looking up a single inspection in the FDA inspection database tells you one data point. Analyzing the full inspection history reveals the compliance story.

Red Flags in FDA Inspection History

Pattern 1: Escalating Classifications

This pattern shows deteriorating compliance and FDA losing patience. Expect more frequent inspections and possible enforcement beyond warning letters.

Pattern 2: Repeated VAI Classifications

Multiple VAI outcomes suggest systemic quality issues that the facility hasn't fully addressed. While not triggering OAI, this pattern indicates a facility struggling to maintain compliance.

Pattern 3: OAI Without Warning Letter

This is unusual and may indicate: (1) firm negotiated resolution privately, (2) warning letter in draft but delayed, or (3) FDA proceeding directly to consent decree. Requires follow-up investigation.

Pattern 4: Long Inspection Gaps

Gaps longer than 3-4 years may indicate the facility is low-priority for FDA, which could mean either excellent compliance history or limited product significance. Check if product mix changed.

Pattern 5: Foreign Facility Infrequent Inspections

Foreign facilities often have longer intervals between inspections. A single VAI after many years may not be concerning unless observations are serious.

Positive Patterns in FDA Inspection History

Consistent NAI Classifications

This is the gold standard. Regular inspections with no objectionable conditions demonstrate mature quality systems.

Quick VAI Recovery

A VAI followed by NAI within 12-18 months shows effective corrective action and FDA confidence restored.

Routine Inspection Frequency

Regular, predictable inspection schedules indicate FDA views the facility as routine risk, neither elevated nor exempt from oversight.

Using FDA Inspection Database for Due Diligence

Regulatory professionals use the FDA inspection database extensively for supplier qualification, M&A due diligence, and competitive analysis.

Supplier Qualification Checklist

When evaluating a contract manufacturer or API supplier:

M&A Due Diligence Using Inspection Data

Before acquiring a pharmaceutical or device company:

Step 1: Comprehensive Facility Mapping

• Obtain complete list of all owned and contracted manufacturing sites
• Search FDA inspection database for each FEI
• Map inspection history for every facility that will transfer in the deal

Step 2: Risk Quantification

• Calculate % of facilities with clean inspection records (NAI)
• Identify any facilities with OAI or warning letters unresolved
• Estimate remediation costs for outstanding compliance issues
• Project timeline to resolve any regulatory holds

Step 3: Pipeline Impact Assessment

• Cross-reference facilities with inspection issues to product pipeline
• Determine if any pending applications are at risk due to inspection findings
• Assess whether facility issues could delay product approvals post-acquisition

Step 4: Post-Acquisition Inspection Likelihood

• Note when each facility was last inspected
• Facilities not inspected in 3+ years likely due for inspection
• Budget for potential re-inspections triggered by ownership change notifications

Common FDA Inspection Database Search Errors

Search Pitfall 1: Wrong Facility Name Format

Problem: Searching "Pfizer Inc." vs "Pfizer" vs "Pfizer Manufacturing"

Solution:

• Use partial name searches without legal suffixes (Inc., LLC, Ltd.)
• Try abbreviations and full names
• Search by city + partial name if full name search returns no results

Search Pitfall 2: Missing Multi-Site Companies

Problem: Large companies have dozens of FEIs across multiple states and countries

Solution:

• Search by parent company name, then map all FEIs found
• Check state-by-state if company has known facilities
• Use establishment registration databases to identify all sites first

Search Pitfall 3: Assuming Recent Data

Problem: FDA inspection database posting lags real-time inspections by 30-90 days

Solution:

• Classification appears 30-90 days post-inspection
• Warning letters post 3-6 months after inspection
• Don't assume "no recent inspection" means facility wasn't inspected recently

Search Pitfall 4: Ignoring Historical Context

Problem: Viewing a single VAI classification without historical pattern

Solution:

• Always pull minimum 3-year history
• Compare current classification to facility's pattern
• Single VAI after string of NAI is less concerning than repeat VAI

Search Pitfall 5: Not Cross-Referencing Databases

Problem: Checking only Inspection Classification Database

Solution:

• Search warning letters separately
• Check recalls database for the FEI
• Look for import alerts
• Review product approval databases for application impacts

FDA Inspection Database vs International Inspection Records

While the FDA inspection database is comprehensive for U.S. regulatory purposes, global manufacturers must also track international inspection records.

Global Inspection Database Comparison

Using FDA Inspection Database for International Facilities

Foreign facilities appear in the FDA inspection database if they:

• Manufacture products for the U.S. market
• Are registered with FDA as foreign establishments
• Have been inspected by FDA investigators

Key differences for foreign facilities:

• Inspection frequency is generally lower (every 4-5 years vs. 2-3 years for domestic)
• Travel logistics may delay re-inspections after VAI or OAI
• Warning letters may take longer to issue due to international coordination
• Import alerts are more common enforcement mechanism than warning letters

Key Takeaways

Next Steps

Understanding how to search the FDA inspection database is essential, but manually tracking inspection updates, classification changes, and warning letters across multiple suppliers is time-intensive and prone to gaps.

Need automated inspection monitoring? Assyro's regulatory intelligence platform tracks FDA inspection database updates, flags classification changes for your supplier network, and alerts you to new warning letters affecting your supply chain. See how continuous compliance monitoring protects your submissions.

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