Sung Park

Sung provides counsel for FDA-regulated companies in enforcement, regulatory, and transactional matters, with clients seeking his advice and representation during both the pre-market and post-market phases of product life cycles. Sung guides companies in developing, distributing, and marketing their products and, when necessary, in responding to regulatory and administrative enforcement actions by federal and state agencies such as FDA, USDA, and state attorney general offices. This includes responding to warning letters, untitled letters, Form 483 Notice of Inspectional Observations, import refusals, placement on import alerts, and others.

Sung’s significant experience includes reviewing product labels and promotional materials, and working with FDA district offices and headquarters to minimize potential regulatory risk and ensure the companies’ supply chains are not disrupted. He also provides FDA counsel in various transactional matters, including M&A and public offerings, and during negotiation and drafting of business arrangements, such as contract manufacturing agreements, supply agreements, quality agreements, transition service agreements, and others. Sung understands the unique business landscape of FDA-regulated products and provides practical advice that suits the needs of clients’ businesses.