Below are answers to the questions our clients ask most often about FDA regulatory compliance. If you don’t see your question here, contact us directly — we’re happy to help.
What does an FDA regulatory compliance attorney do?
An FDA regulatory compliance attorney helps businesses navigate federal regulations for foods, drugs, dietary supplements, cosmetics, and medical devices. Services include label and ingredient reviews, FDA registration, responding to Warning Letters, preparing for FDA inspections, and developing compliance programs tailored to your specific product category.
Do I need an attorney to register with the FDA?
While FDA registration can be completed without an attorney, errors in the process can cause costly delays or downstream compliance problems. An experienced FDA attorney ensures your registration is accurate, complete, and submitted correctly — this is especially important for drug establishment registration, NDC labeler code applications, and Foreign Supplier Verification Program (FSVP) requirements.
What happens if I receive an FDA Warning Letter?
An FDA Warning Letter is an official notification that the agency has identified a serious regulatory violation. You typically have 15 business days to respond in writing. A timely, well-crafted response is critical — it can prevent escalation to injunctions, product seizures, import alerts, or criminal referrals. Capote Law Firm assists businesses in drafting comprehensive, responsive submissions to the FDA.
What is the difference between FDA registration and FDA approval?
FDA registration means a facility or establishment has notified the FDA of its existence and operations — it does not mean the FDA has reviewed or approved the products manufactured there. FDA approval is a separate, more rigorous process required for new drugs (via NDA or ANDA), biologics, and certain medical devices (via PMA or 510(k)) before they may be marketed in the United States.
Does Capote Law Firm serve clients outside of Florida?
Yes. While headquartered in Miami, Florida, Capote Law Firm represents businesses throughout the United States before the FDA, the Consumer Product Safety Commission (CPSC), and U.S. Customs and Border Protection (CBP). We serve clients in all industries regulated by these agencies, from startups to Fortune 500 companies.
Have more questions about FDA regulatory compliance? Capote Law Firm provides personalized regulatory guidance for businesses at every stage. Contact us today or call (786) 207-1174 to schedule a consultation.