FDA WARNING_LETTER - San Diego Ambulatory Surgery Center, LLC

The FDA issued a Warning Letter to San Diego Ambulatory Surgery Center, LLC, for misbranding the LapBand gastric banding system through its marketing, including via 1-800-GET-THIN. The LapBand is a restricted device, requiring prescription and adherence to specific advertising regulations.

The FDA found the center's advertising, including billboards and inserts, violated sections 502(q), 502(r), and 201(n) of the Federal Food, Drug, and Cosmetic Act. Violations include failing to reveal material facts such as relevant risk information, age and qualifying requirements, and the need for ongoing dietary modifications, making the advertisements misleading. Additionally, the advertisements did not adequately state the LapBand's relevant warnings, precautions, side effects, and contraindications, and risk information was presented in illegibly small font.

The FDA demands immediate cessation of non-compliant marketing and prompt corrective actions. Failure to comply may result in regulatory actions such as seizure, injunction, and civil money penalties. The center must respond within fifteen working days, detailing corrective steps, prevention plans, and documentation.