FDA Regulatory Compliance Counsel for Fort Lauderdale, Florida Businesses
Capote Law Firm provides FDA regulatory compliance counsel to businesses throughout Fort Lauderdale and Florida. Whether you manufacture dietary supplements, cosmetics, food products, or medical devices, our firm helps you understand your FDA obligations, maintain compliance, and respond effectively when the FDA comes knocking.
Serving Broward County, Boca Raton, Deerfield Beach, Pompano Beach, and surrounding South Florida communities. Although our office is based in Miami, we represent clients across Florida and nationwide — FDA regulatory matters are federal, and geography is no barrier to effective representation.
Serving Fort Lauderdale-area businesses since 2006. Call (786) 207-1174 or schedule a free consultation to discuss your FDA compliance needs.
FDA Compliance Services We Provide
We advise Fort Lauderdale-area companies across all FDA-regulated product categories:
- Dietary Supplements: Label reviews, cGMP compliance, structure/function claims, FDA registration, Amazon certification, and product recalls
- Cosmetics: MoCRA compliance, facility registration, product listing, adverse event reporting, labeling and claims review
- Food: FSMA compliance, Foreign Supplier Verification Program (FSVP), facility registration, and labeling
- OTC Drugs & Homeopathic Products: OTC monograph compliance, labeling review, and NDA preparation
- Medical Devices: 510(k) submissions, FDA registration, quality system regulations, and UDI compliance
FDA Enforcement: What Fort Lauderdale Businesses Need to Know
Florida is one of the most active states for FDA inspections and enforcement activity. The FDA’s Southeast and Southwest district offices regularly inspect facilities in Fort Lauderdale and the surrounding region. Common enforcement actions our Fort Lauderdale-area clients face include:
- FDA Warning Letters — citing labeling violations, cGMP deficiencies, or unauthorized drug claims
- FDA Form 483 Observations — issued at the close of a facility inspection, requiring a written response within 15 business days
- Import Alerts — automatic detention of all products from a facility placed on alert
- Product Recalls — voluntary or mandatory recall proceedings for unsafe or misbranded products
- MoCRA Non-Compliance — enforcement of cosmetics facility registration, product listing, and adverse event reporting requirements
If your Fort Lauderdale business has received an FDA warning letter, a Form 483, or an import alert — or if you want to get ahead of compliance issues before an inspection — Capote Law Firm can help.
Why Fort Lauderdale Companies Choose Capote Law Firm
- Founded 2006 — nearly two decades of FDA, CPSC, and CBP regulatory experience
- Boutique practice — you work directly with Lisa Capote, not passed to junior associates
- Nationwide reach — FDA compliance is federal; we represent clients across the U.S. and internationally
- Bilingual service — Hablamos Español, serving Fort Lauderdale’s diverse business community
- Full-service compliance — from pre-market label review to emergency warning letter response
Frequently Asked Questions
Do I need to travel to Miami to work with Capote Law Firm?
No. We work with clients throughout Fort Lauderdale and Florida remotely. Consultations are available by phone or video call. FDA regulatory matters are federal, so our location does not limit what we can do for your business.
How quickly can you respond to an FDA issue?
We respond to urgent FDA matters — warning letters, Form 483s, import alerts — on a same-day or next-day basis. If your business has received an enforcement action, call (786) 207-1174 immediately.
What industries do you serve in Fort Lauderdale?
We serve any business that sells or distributes FDA-regulated products in the U.S., including dietary supplement brands, cosmetics and beauty companies, food manufacturers and importers, OTC drug companies, and medical device manufacturers and distributors.
Ready to talk? Call (786) 207-1174 or request a free consultation. Available Monday–Friday, 9 AM–5 PM.