Upload your product label and get an instant AI-powered FDA compliance report — violations, CFR citations, and actionable fixes in under 60 seconds. No account needed.
Our FDA specialists provide a full certified audit with corrected label copy, precise CFR citations, and written regulatory sign-off — accepted by FDA investigators.
⭐ Trusted by importers, brand owners, and contract manufacturers
Disclaimer: This AI-generated report is for educational purposes only and does not constitute legal or regulatory advice. It may not identify all compliance issues — particularly those dependent on product formulation, intended use context, or recent FDA guidance updates. Always consult a qualified FDA regulatory consultant before making labeling decisions. Get a certified review →
Frequently Asked Questions
About the FDA Label Checker
Is this FDA label compliance checker free? ▼
Yes, completely free. Upload your label image or PDF and receive a full compliance report with CFR citations, violation findings, and recommended fixes — no credit card, no account required.
What types of labels can I check? ▼
The tool checks food & beverage, OTC and prescription drug, medical device, cosmetic (including MoCRA), dietary supplement, and veterinary product labels — covering all major FDA-regulated categories under 21 CFR.
What FDA regulations does it check against? ▼
The tool checks against 21 CFR Parts 101 (food), 201 (drugs), 701 & 740 (cosmetics), 801 (devices), 101.36 & DSHEA (supplements), and 500–599 & AMDUCA (veterinary). It also covers FALCPA, the FASTER Act sesame allergen rule, MoCRA facility registration, and UDI requirements.
How does the two-pass AI analysis work? ▼
Pass 1 extracts every word, number, symbol, and panel layout from your label image. Pass 2 runs a senior FDA regulatory consultant AI against the full CFR checklist for your product category — cross-referencing every element for compliance. This two-step approach significantly reduces missed violations compared to single-pass tools.
Is the AI analysis accurate enough to use for compliance decisions? ▼
The tool is highly accurate for identifying common labeling violations and missing required elements. However, it is an educational screening tool — not a substitute for a certified regulatory review. For FDA submission, import, or product launch decisions, we recommend a certified review by an Orionex FDA specialist who can provide written sign-off.
What file formats are supported? ▼
JPG, JPEG, PNG, WEBP, and PDF (up to 10MB). For multi-panel labels, upload a PDF with all panels included — the tool analyzes every page.