TCM Supply Corporation – FDA Warning Letter, Apr 25, 2012

On August 16, 2012, the FDA issued a Warning Letter to TCM Supply Corporation following an inspection from March 6 to April 25, 2012. The inspection revealed that the firm's devices, including TDP Electronic Health Lamps, Synatron 2000, and various acupuncture needles, were adulterated and misbranded.

The devices were found to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Specific QS violations included failure to establish procedures for corrective and preventive action (820.100(a)), maintain complaint files and procedures (820.198(a)), ensure purchased products conform to requirements (820.50), establish incoming product acceptance procedures (820.80(b)), establish finished device acceptance procedures (820.80(d)), identify products to prevent mix-ups (820.60), maintain device history records (820.184), maintain device master records (820.181), control documents (820.40), conduct management reviews (820.20(c)), and conduct quality audits (820.22).

Additionally, devices were misbranded under 21 U.