FDA WARNING_LETTER - Valencia Ambulatory Surgery Center, LLC

The FDA issued a Warning Letter to Valencia Ambulatory Surgery Center, LLC, and CEO Cindy Omidi, regarding the marketing of the LapBand gastric banding system, often promoted via 1-800-GET-THIN. The FDA determined that the firm's promotion misbrands the LapBand, a restricted medical device, under sections 502(q), 502(r), and 201(n) of the Federal Food, Drug, and Cosmetic Act. Key violations include advertisements failing to reveal material facts, such as relevant risk information, age/qualifying requirements for the procedure, and the necessity for ongoing eating habit modification, rendering them misleading under section 201(n) and misbranded under 502(q). Furthermore, advertisements do not adequately state the LapBand’s relevant warnings, precautions, side effects, and contraindications, leading to misbranding under section 502(r). The FDA also noted concern that risk information provided was in illegibly small font. The firm is required to immediately cease marketing the LapBand with violative advertising and respond within fifteen working days detailing corrective actions, preventative measures, and supporting documentation. Failure to comply may result in regulatory actions like seizure, injunction, or civil money penalties.