Are FDA Audits Public? (w/Examples) + FAQs

Yes, FDA audits are public records. The Freedom of Information Act (FOIA) grants citizens the right to access federal government records, including FDA inspection findings. Form FDA 483s, Warning Letters, Establishment Inspection Reports (EIRs), and Import Alerts all fall under public disclosure rules. However, the FDA must redact trade secrets and confidential commercial information before releasing these documents—a process that can take months and cost money depending on your request type.

Roughly 48 million Americans get sick from foodborne diseases each year, with 128,000 hospitalizations and 3,000 deaths annually. These statistics drive why FDA inspection transparency matters for public health. When companies receive violations, the public has a legitimate interest in knowing whether their food, medications, or medical devices meet safety standards.

In this article, you will learn:

📋 How to access different types of FDA audit records—and which ones are free versus fee-based

🔍 The exact FOIA process with step-by-step instructions, timelines, and costs for obtaining inspection reports

⚠️ Real-world examples of companies that received public FDA 483s and Warning Letters—plus what happened next

🛡️ What information stays confidential (trade secrets) versus what becomes public knowledge

💡 How to use FDA’s free public databases to research any company’s compliance history before doing business with them

What Are FDA Audits and Inspections?

FDA audits—officially called “inspections”—are examinations of facilities that manufacture, process, pack, or hold FDA-regulated products. The Federal Food, Drug, and Cosmetic Act (FD&C Act) gives the FDA legal authority to conduct these inspections without prior notice.

Investigators check whether companies follow Current Good Manufacturing Practice (CGMP) regulations. These regulations appear in Title 21 of the Code of Federal Regulations. For pharmaceutical manufacturers, that means 21 CFR Parts 210 and 211. For medical device companies, 21 CFR Part 820 applies.

FDA inspections cover a wide range of industries:

When an inspector finds violations during an inspection, they issue a Form FDA 483—a document listing “inspectional observations.” This form notifies company management of conditions that may violate FDA laws or regulations. The FDA then classifies the inspection based on what happens next.

Types of FDA Inspections: What Triggers Each One

The FDA conducts four main types of inspections, each with a different purpose and trigger mechanism.

Surveillance (Routine) Inspections

These happen on a regular schedule based on a facility’s risk profile. The FDA prioritizes facilities that manufacture:

• Sterile injectable drugs (highest risk)
• Biological products
• Large-volume production operations
• Products with previous compliance issues

Routine inspections verify ongoing compliance with CGMP requirements. A facility might go years between routine inspections if it has a clean compliance history and makes lower-risk products.

Pre-Approval Inspections (PAI)

When a company submits a New Drug Application (NDA), Biologics License Application (BLA), or Premarket Approval (PMA) for a medical device, the FDA often inspects the manufacturing facility before granting approval. The agency conducts these inspections for about 20% of application reviews.

Pre-approval inspections verify that:

• Manufacturing processes match what the application describes
• The facility can produce the product consistently
• Submitted data is accurate and complete

You typically receive five days’ advance notice unless your company has prior violations—then you might get no notice at all.

For-Cause Inspections

A “for-cause” inspection happens when the FDA has specific concerns about a facility. Common triggers include:

• Consumer complaints
• Adverse event reports
• Whistleblower tips
• Product recalls
• Previous inspection failures

These inspections often arrive without warning. Investigators will focus on the area of concern but may expand their scope if they find additional problems.

Compliance Follow-Up Inspections

If your facility received a Form 483 or Warning Letter, the FDA may return to verify that you completed your corrective actions. This is your second chance to prove you fixed the problems. Failing to show improvement often leads to enforcement actions.

FDA Inspection Classifications Explained

After an inspection, the FDA evaluates findings and assigns one of three classifications:

The FDA typically issues its final inspection classification within 45 to 90 days after the inspection concludes.

NAI is the best outcome—think of it as passing with flying colors. The inspector found nothing wrong.

VAI means problems exist, but they are not severe enough to trigger enforcement. A VAI classification typically means the facility received a Form FDA 483. The company should address these issues voluntarily to avoid escalation.

OAI is serious. This classification often leads to Warning Letters, Import Alerts, product seizures, or even injunctions. In FY2024, 47 warning letters went to medical device companies—a 96% increase from 24 letters in FY2023.

What FDA Records Are Public? A Complete Breakdown

Form FDA 483 (Inspectional Observations)

Form FDA 483s are public records available through FOIA. Anyone can request any Form FDA 483. The FDA publishes a subset of 483s on its website, but not all are posted for easy access.

Where to find them:

• OII FOIA Electronic Reading Room – Free access to frequently requested 483s
• FDA Data Dashboard – Searchable inspection data
• FDA Inspection Observations page – Statistics on issued 483s

Important: When you request a Form FDA 483 from the FDA, that request itself is also public information. Companies, investors, news media, and unions regularly request competitors’ 483s.

Warning Letters

Warning Letters are the FDA’s principal tool for achieving voluntary compliance. These letters identify serious regulatory violations and give companies a chance to correct problems before facing enforcement action.

All Warning Letters are publicly posted on FDA.gov. You can search by:

• Company name
• Date issued
• Issuing office
• Subject matter
• Whether a response or closeout letter exists

The FDA has issued thousands of Warning Letters over the years. For example, in 2025, Catalent Indiana, LLC received a Warning Letter for CGMP violations including contamination issues with drug product stoppers.

Establishment Inspection Reports (EIRs)

The Establishment Inspection Report is a comprehensive document created after an FDA investigation. It details everything the inspector reviewed: facilities, processes, documents, and any violations found. EIRs can be requested through FOIA.

Under Field Management Directive (FMD) 145, the FDA provides a copy of the EIR’s narrative portion to the inspected facility once the inspection is “closed.” This happens before public disclosure through FOIA.

EIRs include:

• Inspection scope and context
• Documents reviewed or collected
• Inspectional observations (beyond the 483)
• Samples and evidence collected
• Enforcement recommendations

Import Alerts

Import Alerts are publicly searchable on FDA.gov. These alerts notify FDA field offices that certain products or companies appear to violate FDA laws. When a company appears on an Import Alert, their products may be detained without physical examination (DWPE).

Import Alert lists include:

• Red List: Products/firms subject to DWPE
• Green List: Products/firms exempt from DWPE
• Yellow List: Products/firms under enhanced scrutiny

Competitors, customers, and the public can see when a company gets added to an Import Alert. This visibility is why companies work hard to get removed quickly.

Recall Databases

FDA recalls are public information available through multiple databases:

• Recalls, Market Withdrawals & Safety Alerts – All FDA-regulated products
• Drug Recalls – Pharmaceutical products
• Medical Device Recalls – Devices classified since November 2002

Adverse Event Reports

The FDA Adverse Event Reporting System (FAERS) is a public database containing adverse event reports, medication errors, and product quality complaints. Healthcare professionals and consumers can search this database to identify safety patterns.

How to Access FDA Audit Records: Step-by-Step FOIA Guide

Step 1: Check Free Public Resources First

Before filing a FOIA request, search these free FDA resources:

The FDA makes records available for five years before archiving. For older content, search the FDA Archive.

Step 2: Prepare Your FOIA Request

If the record you need is not publicly available, you must file a FOIA request. Gather this information to ensure an efficient search:

• Exact name and complete address of the inspected facility
• Specific dates or date range of the inspection
• The FDA District Office that conducted the inspection (if known)
• The FDA Establishment Identifier (FEI) number (if available)
• Details about specific products or manufacturing lines

Pro Tip: The FEI number significantly speeds up the search process.

Step 3: Submit Your Request Online

As of March 2020, the FDA asks that all FOIA requests be submitted through its online portal:

Write your request clearly and concisely. Be as specific as possible. The more targeted your request, the faster you will receive documents.

Include a statement about the maximum amount you are willing to pay. For example: “If the cost of providing these documents exceeds $150, please contact me first for authorization.”

Step 4: Understand the Fees

FOIA fees vary based on requester type:

Certifications cost $10 each. Computer charges reflect actual costs for retrieval time. If total fees are expected to exceed $250, the FDA may require payment in advance.

Note: Effective October 1, 2025, the FDA no longer accepts checks—only credit cards and wire transfers.

Step 5: Wait for Processing

FOIA provides 20 business days for an agency to respond to your request. This response is just an acknowledgment—not the actual documents.

Real-world processing times vary dramatically:

The FDA may invoke a 10-business-day extension for “unusual circumstances” such as searching multiple locations or consulting with other agencies.

Step 6: Review Redactions and Appeal if Necessary

Before releasing documents, the FDA must redact trade secrets, confidential commercial information, and other protected material. Common redactions include:

• Manufacturing processes or techniques
• Product formulas
• Vendor and supplier names
• Proprietary assays
• Unique combinations of generally known concepts

If you believe the FDA improperly denied your request, you can appeal within 60 days. Send a letter clearly marked “Freedom of Information Act Appeal” to the FDA’s FOIA staff.

Real-World Examples: Public FDA 483s and Warning Letters

Scenario 1: Pharmaceutical Manufacturer with Repeat Violations

Company: Pfizer (Legacy Hospira Plant in McPherson, Kansas)
What Happened: An FDA Form 483 from October 2017 showed 10 observations—four were repeats from earlier inspections. The FDA’s frustration over recurring issues led to a formal Warning Letter.

Outcome: Pfizer lost potential sales and received a Complete Response Letter for its Epogen biosimilar. The VAI classification eventually upgraded, but not before significant reputational and financial damage.

Scenario 2: Medical Device Company with Wellness Claims

Company: WHOOP (Fitness Tracking Wearables)
What Happened: In July 2025, the FDA issued a Warning Letter to WHOOP over its “Blood Pressure Insights” feature. The company marketed this as a wellness tool providing daily blood pressure estimates—but the FDA determined it functioned as an unapproved medical device.

Outcome: This case demonstrates how the FDA increasingly focuses on wearable products generating physiological metrics associated with medical diagnoses—even when marketed for “wellness.”

Scenario 3: Drug Contract Manufacturer with Contamination Issues

Company: Catalent Indiana, LLC
What Happened: A November 2025 Warning Letter cited significant CGMP violations including mammalian hair contamination in finished drug products.

Outcome: Recalls were initiated for affected products. The company must provide detailed updates on supplier quality investigations and sterile process validation.

What Information Stays Confidential?

Not everything in FDA files becomes public. The agency protects certain categories of information under FOIA Exemption 4 and 21 CFR Part 20.

Protected Information Categories

Trade Secrets: A trade secret is “a secret, commercially valuable plan, formula, process, or device used for making, preparing, compounding, or processing trade commodities” that is the product of innovation or substantial effort.

Examples include:

• Manufacturing processes or techniques
• Product formulations
• Unique assay methods
• Proprietary clinical endpoints

Confidential Commercial Information: This covers information that is:

1. Customarily kept private by the company
2. Shared with assurance it will remain secret

The FDA applies a “foreseeable harm” test—disclosure must be reasonably expected to cause genuine harm to economic or business interests.

How Companies Protect Information

To protect sensitive information in FDA submissions:

1. Mark proprietary information clearly when submitting documents
2. Place trade secrets in designated sections of applications
3. Provide written justification for confidentiality claims
4. Monitor FOIA requests for your documents
5. Object promptly if the FDA plans to release protected material

The FDA solicits company input before releasing information it identifies as potentially confidential. Companies have an opportunity to argue against disclosure.

The 15-Day Response Rule: What You Must Know

When the FDA issues a Form 483, companies must respond in writing within 15 business days. This is not a suggestion—it is a critical deadline that directly impacts what happens next.

What a Strong Response Includes

The response should be signed by a senior management official. This signals that leadership takes the observations seriously.

Common Response Mistakes to Avoid

Warning Letter Response Timeline

Warning Letters require a response within 15 business days of receipt. The response must:

• Acknowledge the letter
• Detail corrective actions taken or planned
• Provide implementation timelines
• Include supporting documentation

After you respond, the FDA may schedule a follow-up inspection to verify corrections. Missing commitments or deadlines can lead to enforcement actions including seizures, injunctions, or criminal prosecution.

Warning Letters vs. Untitled Letters: Key Differences

The FDA uses two types of correspondence to warn about violations. Understanding the difference matters for your response strategy.

Warning Letters are for violations that may lead to enforcement action if not corrected. They are titled “WARNING LETTER” and sent to the highest known official via overnight mail.

Untitled Letters address violations that do not meet the threshold for Warning Letters. They request—but do not require—a response.

There is also a third type: Cyber Letters. These are sent to websites selling unapproved or illegal prescription drugs online. They warn operators about potentially illegal activities.

Using FDA Databases for Due Diligence

For Businesses: Vendor and Supplier Research

Before partnering with a manufacturer, check their compliance history. Use the FDA Data Dashboard to search:

• Inspection classifications (NAI, VAI, OAI)
• Warning Letter history
• Recall records
• Import refusal data

Multiple warning letters or OAI classifications indicate compliance risk. This information can protect your business from partnering with unreliable suppliers.

For Consumers: Product Safety Research

The FDA provides tools to research product safety:

• FAERS Public Dashboard: Search adverse event reports for medications
• MAUDE Database: Medical device adverse event reports
• Recall Databases: Find recalled products by brand or company

For Investors: Risk Assessment

Publicly traded pharmaceutical and medical device companies face material risks from FDA enforcement. Investors use 483s and Warning Letters to:

• Identify compliance weaknesses
• Assess management response quality
• Evaluate potential approval delays
• Gauge regulatory risk exposure

Investment firms regularly request competitors’ 483s through FOIA to inform trading decisions.

Do’s and Don’ts for FDA Audit Transparency

Do’s

Don’ts

Pros and Cons of FDA Audit Transparency

Pros of Public Access

Cons of Public Access

State-Level Considerations

While FDA inspections fall under federal jurisdiction, state agencies play important roles in food safety and pharmacy oversight.

FDA-State Partnerships

The FDA maintains Memoranda of Understanding (MOUs) with state agencies to coordinate inspection efforts. For example:

• California Department of Public Health: Coordinates food protection with FDA
• Utah Department of Agriculture and Food: Expands food protection efforts
• State Boards of Pharmacy: Regulate compounding pharmacies

These partnerships help maximize inspection coverage while avoiding redundant facility visits.

State Inspection Records

State health departments often publish their own inspection reports. The Association of Food and Drug Officials maintains links to state-specific portals where you can access restaurant and food facility inspections.

State records follow different disclosure rules than federal FOIA. Some states provide easier access; others have more restrictions. Check your state’s public records laws for specific requirements.

Dual Jurisdiction Establishments

Some facilities fall under both FDA and state jurisdiction. For food operations, the FDA and state agencies exchange information about these establishments through formal agreements. This coordination affects:

• Inspection frequency
• Information sharing between agencies
• Enforcement coordination

FDA Inspection Statistics: Current Trends

The number of FDA 483s and Warning Letters provides insight into enforcement priorities.

Recent 483 Trends

This upward trend reflects increased inspection activity post-pandemic.

Most Common 483 Observations (2024)

For pharmaceutical manufacturers, the most frequently cited violations include:

1. 21 CFR 211.192 – Investigation failures (171% increase from 2023)
2. 21 CFR 211.113 – Microbiological contamination control
3. 21 CFR 211.67 – Equipment cleaning and maintenance

Warning Letter Surge for Medical Devices

Medical device enforcement reached its highest level in FY2024:

The 96% increase from 2023 to 2024 signals heightened FDA enforcement priorities in the device sector.

FAQs

Can anyone request any FDA 483?
Yes. Form FDA 483s are public records available through FOIA. However, obtaining one can cost money and take months as the FDA redacts confidential information first.

Are FDA Warning Letters always public?
Yes. The FDA posts all Warning Letters on its public website. You can search by company name, date, issuing office, or subject matter without filing a FOIA request.

How long does a FOIA request take?
It varies. Simple requests may process within the 20-day statutory period. Complex requests involving multiple facilities can take months to over a year for certain documents.

Do I have to pay for FOIA requests?
Sometimes. Commercial requesters pay search, review, and duplication fees. Consumers get the first two hours of search and 100 pages of duplication free.

Can the FDA refuse my FOIA request?
Yes. The FDA can deny requests based on FOIA exemptions protecting trade secrets, confidential commercial information, or deliberative process materials. You can appeal denials.

Are FDA inspections announced in advance?
Usually not. Most FDA inspections happen without prior notice. Pre-approval inspections typically give five days’ notice unless the company has previous violations.

How do I find a company’s FDA inspection history?
Use free databases. The FDA Data Dashboard shows inspection classifications, Warning Letters, and recalls. The OII Electronic Reading Room provides select 483s and EIRs.

What happens if I ignore a 483?
Escalation. Failing to respond within 15 business days almost guarantees a Warning Letter. Continued non-response can lead to seizures, injunctions, or criminal prosecution.

Can competitors see my FDA 483?
Yes. When you request a 483, that request itself is public. Companies, investors, and media regularly request competitors’ inspection records through FOIA.

Are adverse event reports public?
Yes. The FAERS database contains adverse event reports for drugs. The MAUDE database covers medical devices. Both are searchable online at no cost.

Do state inspections follow the same rules?
No. State inspection records follow state public records laws, which vary. Some states provide easier access than federal FOIA; others have more restrictions.

How do I protect trade secrets from FOIA disclosure?
Mark them clearly. When submitting documents to FDA, identify trade secrets in writing and place them in designated sections. The FDA will redact properly marked information.