If you're aiming to ensure FDA compliance as you're developing a new product, your company is facing an FDA warning letter, or you're looking for clarity on what to expect in an FDA inspection, turn to Capote Law Firm. We advise businesses on a variety of compliance matters in Miami, Fort Lauderdale, Orlando, Tampa, and worldwide. In addition, we counsel clients on consumer product safety regulations and international issues regarding customs and borders. Schedule a free consultation today to see how we can help you.
Lisa Capote founded Capote Law Firm, a minority, woman-owned practice, in 2006. From the beginning, her goal has been to provide creative solutions, zealous advocacy, and personal service to businesses in Miami and beyond. An award-winning legal professional, Attorney Capote has an in-depth understanding of FDA regulations and more than a decade of experience developing and implementing tailored compliance programs. Whether you are operating a Fortune 500 company or a startup, Lisa will strive to help you gain peace of mind when facing the FDA, the Consumer Product Safety Commission, or U.S. Customs and Border Protection.MORE ABOUT LISA
Serving our clients' needs promptly and professionally is of the utmost importance at Capote Law Firm. We understand that FDA regulations can be complex, and you may have questions or concerns along the way. Don't hesitate to reach out—we'll be here to seek answers or provide reassurance. We genuinely care about you, and we want to make sure that you feel heard, seen, and valued at every step of the legal process.
With more than a decade of experience in the industry and countless successful cases under her belt, our attorney is an advocate you can trust. Attorney Capote won't just provide guidance based on what she thinks will happen—she'll base her advice on what she's actually seen happen in previous cases. Having access to her in-depth knowledge of FDA regulations is invaluable as you strive to create an iron-clad compliance program.
We have been working with Lisa for close to 7-8 years now. Normally, I would leave it like that, because just to say that we have been working that long with someone, in our line of business, is something important...
In a profession where clients have a tendency of easily becoming lost in legal jargon and processes, Ms. Capote has proven a great "interpreter," detailing all documents in a clear, understandable, and candid manner...
In late 2017, a dietary supplement private labeler was inspected by the FDA for the second time. At the first inspection, there were various observations noted. At this second inspection, zero observations were issued. Our firm had been working to establish a compliance program for this labeler that would address all requirements under FDA good manufacturing practices.
At Capote Law Firm, we believe that the key to ensuring your business's compliance with FDA regulations is to be proactive. Seeking the guidance of an experienced attorney as you work to obtain the necessary clearance to place products on the market can help you avoid costly, time-consuming interruptions to your business later on.
FDA-regulated products include dietary supplements, cosmetics, medical devices, drugs, food, and other items that could impact public health. If your company is producing products that fall under FDA-regulated categories, you will be required to follow certain rules regarding manufacturing, labeling, advertising, and more. To ensure compliance with these rules and regulations, the FDA conducts routine inspections.
Receiving violations during an FDA inspection can negatively impact your business's future. Our goal is to provide the counsel you need to gain peace of mind that your business is FDA compliant. From ingredient and labeling reviews, claims analyses, and internal audits, to product development counseling, application preparation, and more, our services are comprehensive. We strive to give our clients the tools necessary to create and implement top-notch compliance programs that will set them up for success.
If your business is regulated by the FDA, be proactive with your compliance. Schedule a free consultation with our attorney at Capote Law Firm in Miami, Florida, today to get started. We serve clients in the surrounding areas of Fort Lauderdale, Orlando, and Tampa, as well as worldwide.