Mega Sun Inc – FDA Warning Letter, Aug 11, 2010

The FDA issued a Warning Letter to Mega Sun, Inc., disapproving their quality control and testing program for sunlamp products (e.g., Models Megasun Slimline, Extreme, Crossfire, Mega V). This action, under the Federal Food, Drug, and Cosmetic Act, prohibits the firm from certifying, introducing, or importing non-compliant or uncertified electronic products into U.S. commerce.

The disapproval stems from a July/August 2010 inspection by FDA investigators, revealing Mega Sun, Inc. failed to establish a quality control and testing program ensuring compliance with federal performance standards for sunlamp products (21 CFR 1040.20) and general electronic products (21 CFR 1010). Specifically, products lacked certification based on good manufacturing practices, as no manufacturing quality control or test records were maintained.

Additionally, Mega Sun, Inc. failed to comply with record-keeping and reporting requirements (21 CFR 1002). Deficiencies included not maintaining descriptions of quality control procedures, test results for radiation safety, or communications concerning radiation safety. The firm also failed to submit required product, supplemental, and annual reports.

Mega Sun, Inc. must immediately provide the number of sunlamp products produced and shipped. Within 15 days, they must respond by refuting the noncompliance, requesting an exemption, or initiating purchaser notification and corrective action. If the latter, they must submit a draft notification letter and