Tinnitus Control, Inc. – FDA Warning Letter, Jun 9, 2009

On March 17, 2010, the FDA issued a Warning Letter to Dr. Daniel S. J. Choy, Chairman & Medical Director of Tinnitus Control, Inc., following an inspection conducted on June 2, 4, and 9, 2009. The inspection determined that Tinnitus Control, Inc. imports a Tinnitus Masker, which is classified as a medical device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The primary violation identified was the firm's failure to comply with annual establishment registration and device listing requirements. Under section 510 of the Act, as amended by the FDA Amendments Act of 2007 (FDAAA), domestic and foreign device establishments must electronically submit their annual registration and device listing information between October 1st and December 31st each year. Tinnitus Control, Inc. failed to fulfill these requirements for the period between October 1 and December 31, 2008, and remained unregistered as of March 17, 2010.

Consequently, all of the firm's devices are deemed misbranded under section 502(o) of the Act because they were processed in an establishment not duly registered under section 510. The FDA mandated prompt corrective action to address these violations, warning that failure to comply could lead to regulatory actions such as seizure