FDA Investigation Attorney: When Compliance Becomes Criminal

Even honest companies can get into serious trouble with the FDA. What starts as a routine check can quickly become a criminal investigation.

If you run a small brand or manage compliance, you need to know what to do fast. That's where an experienced FDA compliance expert from Bustos Law Group comes in.

This guide explains, in plain language, how an FDA inspection can lead to criminal exposure, what the main players do, and how Bustos Law Group's services, like FDA Warning Letter Help, Product Held at Customs, MoCRA Compliance for Cosmetic Brands, support you at every step.

What the FDA does and why it matters

The FDA's job is to keep people safe. The agency checks that food, drugs, cosmetics, and medical devices are safe, made in clean conditions, and honestly labeled. Think of the FDA like a school inspector for products.

When a product is unsafe, mislabeled, or falsely advertised, people can get hurt, and the FDA steps in.

 At Bustos Law Group, you'll find dedicated FDA Compliance & Regulatory Legal Services that cover food, dietary supplements, cosmetics, and medical devices.

They help brands stay ahead of the rules so they don't end up under investigation.

How inspections start

Inspections can happen for many reasons:

• A customer complains about a product.

• A product sample fails lab testing.

• An employee or competitor reports a problem.

• Random checks find something suspicious.

Inspections range from friendly checkups to surprise visits. Inspectors look at manufacturing areas, product labels, test data, and records. They may take samples or copies of documents.

Red Flags That Make an Inspection Dangerous

Not every FDA inspection turns into a criminal investigation, but certain red flags can quickly raise alarms and put your company under deeper scrutiny.

1. False or Misleading Labels

Claims that a product is "FDA approved" when it's not, or suggesting unproven health benefits, are among the most common triggers for FDA action.

2. Evidence of Contamination

Finding bacteria, mold, or unsafe chemical residues in a product or facility shows a breakdown in Good Manufacturing Practices (GMP) and raises serious safety concerns.

3. Use of Unapproved Ingredients

Using ingredients that haven't been cleared, listed properly, or registered with the FDA can violate multiple sections of federal law and prompt an investigation.

4. Dishonesty During Inspection

Lying to inspectors, hiding documents, or obstructing access can instantly shift a case from compliance to potential criminal conduct.

5. Falsified or Altered Test Results

Changing data or forging quality-control reports is considered intentional deception - one of the fastest ways to trigger a referral to the FDA's Office of Criminal Investigations (OCI).

When does a compliance problem become a criminal case?

A criminal case usually requires intent or serious negligence.

Examples include:

• A company continues selling products after receiving tests that show contamination.

• A lab report is intentionally altered to hide test failures.

• Marketing claims make a product look like an approved drug when it is not.

When there is suspected criminal conduct, the FDA can bring in its criminal investigators and refer the case to the Department of Justice (DOJ).

Inside an FDA Investigation: How It Actually Works

When an inspection uncovers serious issues, the FDA begins a deeper investigation to determine how and why those violations happened. This stage is no longer routine; it's focused, evidence-based, and can define your company's future.

FDA Inspectors

FDA inspectors review your facility, manufacturing process, product samples, and documentation. Their goal is to verify whether your operations meet federal safety and labeling standards.

FDA's Office of Criminal Investigations (OCI)

If inspectors find signs of deliberate misconduct such as document tampering, false labeling, or unapproved ingredients, the FDA's Office of Criminal Investigations (OCI) steps in. The OCI gathers evidence, interviews employees, and builds a case to confirm whether the violations were intentional or accidental.

What Your Company Should Do Right Away

If you sense that an FDA inspection might escalate into a deeper investigation, take action immediately but carefully. The first few hours can make all the difference.

Action	What to Do	Why It Matters
Call your FDA investigation attorney	Reach out to your legal counsel before speaking to inspectors or signing any documents.	Early legal guidance prevents costly mistakes.
Preserve all records	Secure all documents, emails, and test results. Do not delete, shred, or edit anything.	Protects evidence integrity and shows good faith compliance.
Instruct your staff	Tell employees not to discuss the inspection except with legal counsel.	Prevents accidental statements or inconsistencies.
Start an internal review	Begin fact-gathering under your attorney's supervision. Keep notes confidential.	Helps you understand what happened and prepare your response.
Stay calm and cooperate	Be respectful with FDA inspectors but avoid volunteering extra information without counsel.	Maintains professionalism and minimizes exposure risk.

How to run an internal investigation the right way

A proper internal review helps you understand the problem and shows regulators you’re trying to fix it. Follow these points:

• Work with counsel so your investigation can be protected by the attorney-client privilege.

• Preserve physical and electronic records immediately.

• Interview key people carefully and document what you learn.

• Collect test data, batch records, and any corrective actions already taken.

• Create a timeline of events based on facts, not opinions.

Your attorney will help you keep sensitive parts of this process privileged so your findings are not fully exposed to regulators.

Fixing problems: remediation that matters

Fast, honest, and documented fixes can change the outcome. Effective remediation includes:

• Stopping the problem immediately (recalls, halting production).

• Fixing processes and retraining staff on good manufacturing practices.

• Running independent tests to confirm safety.

• Documenting every corrective action with dates, signatures, and proof of testing.

• Implementing stronger internal controls and audits.

When regulators see a sincere and documented effort to fix problems, they are less likely to escalate to criminal prosecution.

Compliance Scorecard: Quick Checks for Your Business

Even small compliance gaps can catch the FDA’s attention. Use this simple scorecard to evaluate your business and identify where immediate improvements are needed.

Labels

Do your product claims match the actual evidence and approvals?

False or exaggerated claims can lead to warnings or investigations.

Ingredients

Are all your ingredients approved for use?

Unapproved or unsafe substances can instantly raise red flags during an FDA review.

Manufacturing

Are your facilities clean, records up to date, and processes fully documented?

Proper hygiene and recordkeeping are key signs of compliance.

Testing

Are test results accurate and traceable?

Missing or inconsistent testing data can suggest deeper safety or quality control issues.

Marketing

Are your health claims accurate, supported, and permitted under FDA rules?

Even small marketing errors can be treated as misbranding.

Training

Is your staff fully trained and is that training properly documented?

A trained team reduces mistakes and shows the FDA your company takes compliance seriously.

If you answered "no" to any of these, it's time to act quickly and close those gaps.

Final thoughts: prevention is the best defense

Most criminal investigations stem from ignored warnings, poor records, or deliberate deception.

The best protection is a strong compliance program: honest labeling, clean manufacturing, accurate testing, and good record-keeping.

If you face an FDA inspection that looks serious, contact Bastos Law Group, your FDA compliance or FDA investigations expert, right away.

Early advice and the right actions can prevent compliance issues from becoming criminal.