National Therapy Products, Inc. – FDA Warning Letter, Jun 21, 2011

During a June 20-21, 2011, inspection, the FDA determined that National Therapy Products, Inc. manufactures Wavelength Ultrasound Gel, classified as a device. The inspection revealed the devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), due to failure to furnish material or information required by section 519 of the Act and 21 CFR Part 803 - Medical Device Reporting.

Specifically, the firm failed to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. The firm stated no serious injuries or malfunctions had occurred and did not produce a procedure for evaluating and handling reportable adverse events.

Additionally, the FDA noted nonconformances with section 501(h) of the Act (21 U.S.C. § 351(h)), indicating deficiencies in the firm's quality system pertaining to current good manufacturing practice requirements specified in 21 CFR Part 820. This includes the failure to establish procedures for quality audits and to conduct such audits to assure quality system compliance and effectiveness, as required by 21 CFR 820.22. Quality procedures have not been established, and internal audits have not been conducted since 2007