FDA WARNING_LETTER - Hontech Foundation for Medical Technology - May 08, 2008

On June 10, 2008, the FDA issued a Warning Letter to Hontech Foundation for Medical Technology following an inspection from January 9 to March 3, 2008, and May 8, 2008. The firm, located in Westford, Massachusetts, was identified as an importer, repackager, and initial distributor of the medical device "Electronic Itch Stopper." The inspection revealed the device was adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act, as the firm's methods, facilities, or controls did not conform to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 C.F.R. Part 820).

Key violations included: 1. Failure to establish quality system procedures and instructions (21 C.F.R. § 820.20(e)), with management unaware of QS regulations. 2. Failure to establish, maintain, and document procedures for corrective and preventive actions (21 C.F.R. § 820.100). 3. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints (21 C.F.R. § 820.198(a)). 4. Failure to establish and maintain procedures to ensure purchased products and services conform to requirements (21