Contact
← All workflows

Labeling Compliance Review

FDA Labeling Compliance Reviews in Minutes, Not Hours

12 minutes with CaseMark

Fast lane

We have it from here.

Choose the fast one-off run here, or jump into the workspace when you want saved history, revisions, and a fuller matter workflow.

Run this once here

Best for a quick one-off job. Add your email, upload the files, and we'll run the workflow and send the result to your inbox.

1. Add your email so we know where to send the result.

2. Upload the files you want analyzed.

3. Run the workflow and we'll take it from there.

Use in Workspace

Best for ongoing matters

Save and reopen matters, keep documents together, refine the output, rerun with changes, and export or share polished work product when you're done.

Open in Workspace

Need more context?

Scroll for the workflow details below if you want to review what this run handles, what documents help, and what the output looks like.

If this is part of a live matter, the workspace is the better fit: you can keep your documents together, revisit the result, and keep working without starting from scratch.

Jump to detailsOpen in Workspace

Start here

Run this workflow now

Best for a fast one-off run. Add your email, upload the files, and we'll deliver the result without sending you into the full app.

Workflow

Labeling Compliance Review

Step 1 · Deliver to

Step 3 · Run this workflow

Workflow

Labeling Compliance Review

Overview

Manually reviewing product labels against FDA requirements is tedious and time-consuming, requiring cross-referencing multiple regulations, guidance documents, and precedents. A single labeling error can result in warning letters, product recalls, or market delays. Regulatory attorneys and compliance professionals spend hours meticulously checking every claim, warning, and panel requirement to ensure full compliance.

FDA labeling compliance requires meticulous review of complex regulations across multiple product categories, with non-compliance risking warning letters, product seizures, and costly recalls. Manual reviews are time-intensive, requiring regulatory experts to cross-reference dozens of CFR sections, guidance documents, and enforcement precedents. Even minor labeling violations can trigger enforcement actions that damage brand reputation and halt product distribution.

CaseMark automates comprehensive FDA labeling compliance reviews by systematically evaluating every required element against current regulations. Our AI analyzes principal display panels, information panels, claims substantiation, and mandatory warnings to identify compliance gaps and legal risks. Receive actionable recommendations with specific regulatory citations in minutes, ensuring your product labeling meets all FDCA requirements before market entry.

How it works

  1. 1. Upload your documents

  2. 2. AI analyzes and extracts key information

  3. 3. Review and customize the generated content

  4. 4. Export in your preferred format (DOCX, PDF)

What you get

  • Product Information Summary

  • Principal Display Panel (PDP) Compliance Analysis

  • Information Panel Requirements Assessment

  • Claims Review (Structure/Function, Health, Nutrient Content)

  • Required Warnings and Statements Verification

  • Compliance Conclusion and Recommendations

  • Reviewer Certification

What it handles

  • Product Information Summary

  • Principal Display Panel (PDP) Compliance Analysis

  • Information Panel Requirements Assessment

  • Claims Review (Structure/Function, Health, Nutrient Content)

  • Required Warnings and Statements Verification

  • Compliance Conclusion and Recommendations

  • Reviewer Certification

Required documents

  • Product Label

    Complete product labeling including principal display panel and information panel

    .pdf, .jpg, .png, .docx

Supporting documents

  • Product Formulation Details

    Ingredient list, active ingredients, and formulation specifications

    .pdf, .docx, .xlsx

  • Claims Substantiation

    Scientific studies or documentation supporting product claims

    .pdf, .docx

  • Previous FDA Correspondence

    Warning letters, 483 observations, or other FDA communications

    .pdf, .docx, .eml

Why teams use it

Complete labeling compliance analysis in 12 minutes vs. 4+ hours manually

Automated cross-referencing of FDA regulations for drugs, devices, and food products

Instant identification of missing warnings, improper claims, and panel deficiencies

Comprehensive compliance reports with specific regulatory citations and remediation steps

Reduce risk of FDA warning letters and costly labeling corrections post-launch

Questions

What types of products can be reviewed for FDA labeling compliance?

CaseMark's labeling compliance review covers prescription drugs, over-the-counter drugs, medical devices, dietary supplements, conventional foods, and cosmetics subject to FDA oversight. The analysis adapts to the specific regulatory framework applicable to your product category, including specialized requirements for different product classifications. Each review evaluates compliance with the Federal Food, Drug, and Cosmetic Act and relevant sections of 21 CFR.

How does the AI identify prohibited claims or misleading statements?

The system analyzes all express and implied claims against FDA regulations governing health claims, nutrient content claims, and structure/function claims. It cross-references claims with authorized claim databases, evaluates required disclaimers, and identifies language that could cause a product to be considered an unapproved new drug or misbranded device. The analysis also assesses whether the overall impression created by labeling is truthful and not misleading under FDA standards.

Will the review identify all required warnings for my specific product?

Yes, the compliance review systematically verifies all mandatory warnings, contraindications, and cautions specific to your product category and ingredients. This includes allergen declarations, pregnancy warnings, drug interaction cautions, and population-specific warnings required by regulation or guidance. The analysis also considers whether additional warnings may be necessary based on foreseeable misuse scenarios, even if not explicitly mandated.

How current is the regulatory information used in the analysis?

CaseMark's compliance review incorporates current FDA regulations from 21 CFR, recent guidance documents, and enforcement precedents from warning letters and compliance actions. The system accounts for recent regulatory amendments, including updated nutrition labeling requirements and evolving FDA positions on emerging product categories. Each review includes specific regulatory citations so you can verify the applicable requirements independently.

What happens if my label has compliance violations?

The review categorizes violations by severity, distinguishing critical issues that render products misbranded from minor technical deficiencies. You'll receive specific corrective action recommendations with regulatory citations, implementation timelines, and risk assessments regarding potential enforcement actions. The analysis also indicates whether FDA notification or pre-market approval may be required for proposed labeling changes, helping you plan your compliance strategy effectively.

Related

510k Premarket Notification

Draft FDA 510(k) Submissions in Minutes, Not Hours

Adverse Event Reporting Policy

Draft FDA-Compliant Adverse Event Policies in Minutes

Anti-Money Laundering (AML) Compliance Program

Draft AML Compliance Programs in Minutes, Not Days