Brickell is the financial capital of Latin American trade — the banks that finance Miami’s imports, the regional headquarters that direct them, and the executives who make product and market-entry decisions for the hemisphere all sit within a few blocks. Garg Law’s Miami office is here, at 1221 Brickell Avenue, in the middle of that corridor. That concentration of regulated commerce is why Garg Law brings its FDA and customs practice to Brickell businesses from a Miami office on Brickell Avenue — close enough to the port, the airport and the agencies to act the day a problem surfaces. The companies steering FDA-regulated product lines from Brickell towers need regulatory answers at deal speed — and the office handling them is on the same street.
Understanding import compliance programs
Importers of food, dietary supplements, cosmetics, drugs and medical devices answer to two agencies at once. FDA requires facility registrations and product listings — biennial food facility registration, drug and device establishment registration and listing, cosmetic facility registration and product listing under MoCRA — plus prior notice for food, compliant labeling, and for most food importers a documented Foreign Supplier Verification Program (FSVP).
CBP, meanwhile, demands accurate classification, valuation and country-of-origin declarations under the importer’s duty of reasonable care, and enforces partner-agency data filed through ACE at entry. Errors on either side produce detentions, entry rejections, FSVP inspection findings, penalty exposure under 19 U.S.C. § 1592 — and, repeated often enough, an import-alert listing.
Compliance counsel builds the system that prevents all of that: supplier qualification and verification files that survive an FDA inspection, labeling reviews before production runs, correct product coding and affirmations of compliance at entry, broker oversight, and internal procedures so growth in volume does not mean growth in violations.
Acting early vs. waiting: what it costs
Compliance failures rarely announce themselves until a shipment is stopped — then the cost is detention charges, lost sales and enforcement history all at once. FSVP violations are now among FDA’s most-cited import findings, and CBP penalties for entry errors reach multiples of the duty owed.
The engagement, step by step
- Gap assessment across FDA registrations, listings, labeling, FSVP files and CBP entry practices
- Remediation plan ranked by enforcement risk — what FDA and CBP actually act on first
- Supplier verification build-out: qualification, verification activities and the records inspections test
- Labeling and claims review before goods are produced, not after they are detained
- Broker instructions, entry-data protocols and periodic audits that keep the program current as products and suppliers change
Five mistakes that sink these matters
- Assuming the broker or the foreign supplier “handles FDA” — legally, the importer owns it
- Entering food with no FSVP importer identified, or an FSVP file that is a folder of certificates
- Copying a competitor’s label and inheriting its violations
- Letting registrations lapse in the renewal windows and shipping into automatic holds
- Scaling volume with no one auditing what is actually filed in ACE under your bond
Import Compliance Counsel services for Brickell
The work around Brickell — international banking and trade finance, multinational regional headquarters, consumer brand offices, legal and professional services, import/export holding companies — is FDA-regulated at nearly every turn, and matters here move on Miami’s financial district, home to the banks, trade finance desks and regional headquarters that fund and direct hemispheric trade. Garg Law's Miami office is at 1221 Brickell Avenue, and the practice was built for exactly this market: founder Shelly Garg spent years counseling importers at the world's largest dedicated international trade law firm before opening her own, and works at the crossroads of FDA and CBP compliance for foreign and domestic companies across the food, beverage, supplement, cosmetics, OTC drug and medical device industries.
Frequently asked questions
What does “reasonable care” mean for an importer?
It is the legal standard CBP holds importers to for classification, valuation, origin and admissibility declarations. Falling short supports negligence penalties under 19 U.S.C. § 1592 — and written advice from qualified counsel is a recognized pillar of demonstrating reasonable care.
What does FDA check on every import entry?
The electronic screen tests entry data against FDA records: product codes, affirmations of compliance, facility registrations, listings, prior notice for food. Data that does not verify draws holds regardless of whether the underlying product is compliant — entry discipline is compliance.
How often should an import compliance program be audited?
At least annually, and whenever products, suppliers or volumes change materially. Supplier files need reevaluation on defined cycles, and entry-data audits routinely surface broker errors filed under your bond that no one inside the company had seen.
Can good compliance actually reduce FDA screening of my entries?
Yes. FDA’s screening weighs compliance history — clean entries, accurate product codes and affirmations, and resolved issues lower your risk profile over time, which means fewer exams and faster releases. Programs like the Voluntary Qualified Importer Program can formalize that advantage for food importers.
We use a great customs broker — do we still need import counsel?
Brokers execute entries; counsel owns the legal architecture behind them — registrations, verification programs, labeling, penalty defense and the written advice that evidences reasonable care. The strongest import operations in Miami run both, in coordination.