Do you sell products manufactured outside of the USA? Are you adding new SKUs to an established manufacturing concern? Has the FDA arrived at your manufacturing facility for an unannounced inspection?
Mr. Robinson advises Life Science manufacturers regarding federal and state regulations and laws that govern food processing facilities, with a focus on dietary supplements, including responding to Form FDA 483 for GMP compliance and enforcement actions, and FDA Warning Letters. Also, we advise regarding federal regulations for the registration and marketing of cosmetics, medical foods, OTC drugs, and medical devices.
- Federal Trade Commission and National Advertising Division investigations concerning false and misleading advertising;
- Aggressive marketing without violating advertising laws, including website and social media review and strategy;
- Food and drug regulations and laws, with emphasis on dietary supplements, OTC drugs, cosmetics, medical foods, and homeopathic drugs;
- FDA inspections; warning letters and defense of FDA enforcement actions; and reviews of the adequacy of scientific substantiation; and
- Ingredient formulation, manufacturing, and distribution agreements.
