Manufacturers (food and dietary supplement manufacturers, cosmetic manufacturers, manufacturers of housewares and food related products, medical device manufacturers, and manufacturers of drugs and biologics) look to the U.S. market for opportunities to significantly expand their business. With our legal expertise and regulatory compliance services, foreign and domestic manufacturers have support in ensuring regulatory compliance, responding to regulatory enforcement issues and finding new buyers and partners.
Whether you are a foreign or domestic manufacturer seeking to market FDA-regulated products in the U.S., you must ensure that products are compliant with U.S. laws and regulations. Manufacturers of foods, dietary supplements, cosmetics and personal care products, medical devices, Over-the-Counter (OTC) drugs, animal and veterinary products, beverage alcohol, and the products themselves, are subject to inspection when offered for import into the U.S., and/or via routine or surveillance inspections (domestic or foreign). Accordingly, manufacturers must ensure compliance with current Good Manufacturing Practices (GMPs) or Quality Systems, applicable registration and product listing, permits, labeling, recordkeeping, reporting and more. For foods, this may also mean compliance with FDA’s Food Safety Modernization Act (FSMA) including Food Safety and Preventative Controls plans. Manufacturers are also advised to have manufacturing and quality agreements in place with buyers to properly identify and allocate regulatory liability.
Compliance with U.S. requirements for manufacturing helps reduce FDA enforcement costs including costs associated with inspections, product delays, and placement on Import Alert. Compliance also supports consumer confidence, positive trade flow and profitability.