FDA Drug Label Review Services
About FDA Drug Label Review
Drug labels serve as the primary source of information for healthcare professionals and consumers, making accuracy, clarity, and compliance essential for patient safety and regulatory approval. A compliant label not only supports regulatory approval and market access but also protects companies from warning letters, import alerts, recalls, detentions, and enforcement actions.
Labeling is also one of the first things FDA looks at. Because a label can be examined without opening a shipment, testing a sample, or inspecting a facility, it is frequently the trigger for an import refusal or an enforcement action — even when the product itself is manufactured to a high standard. Under Section 502 of the Federal Food, Drug, and Cosmetic Act, a drug is considered misbranded if its labeling is false or misleading, omits required information, or fails to present that information with the required prominence. Misbranding alone is enough to keep a product out of U.S. commerce.
The FDA issues an average of 700–800 warning letters each year, most of which are due to label non-compliance. You can avoid this by opting for our Label Review Service, designed to help prevent potential detention and delays caused by label non-compliance.
At Liberty Management Group Ltd. our experts review your label, identify compliance gaps, and provide a revised, ready-to-use FDA-compliant version—accurately, efficiently, and cost-effectively.
Our regulatory experts support you in the following areas:
- Identification of monograph
- Dosage Form and Strength
- Drug Facts panel requirements
- Marketing taglines and claims
- Overall Formatting and Presentation
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What our review covers
Our review identifies formatting deficiencies, missing or incorrect regulatory statements, inconsistencies, and potential risks that could result in regulatory observations or FDA warning letters. Each review includes detailed comments, recommendations, and actionable revisions to help manufacturers efficiently understand the deficiencies.
We also check for the issues that most often cause avoidable problems at the port and in the market: inactive ingredients listed out of order or incompletely, warnings that have been paraphrased instead of stated as required, missing “Keep out of reach of children” or poison-control language, absent tamper-evident statements where they are required, inconsistent labeler codes and NDC formats, and text that is technically present but too small or too low in contrast to be legible.
FDA Drug Label Review — Frequently Asked Questions
How are OTC drug labels reviewed?
Does the FDA approve drug labels?
Can marketing claims be included on drug labels?
What are the key elements required in an FDA drug label?
- Drug name (established name and pharmacological category)
- Dosage form and strength
- Indications and usage
- Directions for use and Warnings
- Inactive ingredients
- Proper Drug Facts formatting and layout
Are foreign manufacturers subject to the same labeling requirements?
Are there language requirements for drug labels?
What happens if an OTC drug label is non-compliant?
Need Your Drug Label?
Contact our regulatory experts via email or phone, or submit your details through our online form.
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