Anodyne Therapy Systems, an infrared lamp with an ILY classification, were issued a multi-page warning letter from the FDA dated December 2, 2005, pointing out violations of federal law.
January 26, 2006 (Press Release) --
The violations were not only for marketing an "adulterated" product, but for having quality control and reporting problems with the Anodyne Therapy System as well.
According to the letter, the Anodyne system was cleared by the FDA only "for relief of minor muscle and joint pain and improvement of superficial circulation." However, the Anodyne system was advertised on the Internet for use in the treatment of wounds and ulcers, loss of protective sensation, gait and balance impairment, and other diabetic peripheral neuropathy conditions, as well as conditions associated with non-diabetic neuropathies, and the company was cited for promotional efforts towards treatment of soft tissue injuries, carpal tunnel syndrome (CTS), and lymphedema.
http://www.fda.gov/foi/warning_letters/g5660d.htm
Inspection revealed that these devices are adulterated under section 501(h) of the Act [21 U.S.C. 351(h)], in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations observed.
According to the letter, the Anodyne system was cleared by the FDA only "for relief of minor muscle and joint pain and improvement of superficial circulation." However, the Anodyne system was advertised on the Internet for use in the treatment of wounds and ulcers, loss of protective sensation, gait and balance impairment, and other diabetic peripheral neuropathy conditions, as well as conditions associated with non-diabetic neuropathies, and the company was cited for promotional efforts towards treatment of soft tissue injuries, carpal tunnel syndrome (CTS), and lymphedema.
http://www.fda.gov/foi/warning_letters/g5660d.htm
Inspection revealed that these devices are adulterated under section 501(h) of the Act [21 U.S.C. 351(h)], in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations observed.
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