Since we began in 2001, Dunlap Bennett & Ludwig has represented companies in the food, drug, medical device, cosmetic, and tobacco industries. Our attorneys routinely handle FDA-related matters including regulatory, enforcement, and policy issues. We combine our FDA regulatory practice with a unique knowledge of the FDA and considerable familiarity with its procedures. While we represent companies across the United States – and around the world – our locations enable us to meet easily with FDA officials if necessary. Decades of combined legal experience help us to protect the interests of client companies that are dealing with the FDA and FDA-related concerns. Our attorneys have diverse backgrounds – including biotechnology, business, and engineering – and they put those backgrounds and combined decades of legal experience to work for a variety of business clients.
If your company manufactures food items, dietary supplements, medical devices, cosmetics, pharmaceuticals, veterinary medicines, or tobacco products, you may already know about FDA warning letters. FDA warning letters are most frequently received by manufacturers subsequent to an FDA inspection. The most common warnings are for violations of good laboratory practices, violations of good manufacturing practices, and the use of unapproved dietary supplements, food additives, and color additives. A warning letter is considered by the FDA to be informal and advisory. While it conveys the FDA’s position regarding an alleged violation, it does not commit the FDA to further enforcement action as it is intended to compel voluntary compliance, and it creates “prior notice,” a record that you’ve been notified if the FDA subsequently determines that further enforcement action is required.
Dunlap Bennett & Ludwig understands the challenges and needs that FDA-regulated manufacturers confront. We advise our clients regarding the most appropriate response to an FDA warning letter, and if necessary, we will speak with the FDA on your behalf. Often the matter can be quickly resolved. If, however, it cannot be resolved and the FDA takes further enforcement action, Dunlap Bennett & Ludwig can provide comprehensive legal representation and bring the matter quickly to its best possible resolution. If your FDA-regulated company needs a team of sharp, skilled attorneys who will put their diverse backgrounds and decades of legal experience to work for you, Dunlap Bennett & Ludwig is here to serve and protect you and your business.