# FDA WARNING_LETTER - TCM Supply Corporation - April 25, 2012

Source: https://www.keypedia.com/records/warning_letter/tcm-supply-corporation/d26c1326-f570-4d98-a4e5-2af8a41893c4

> FDA WARNING_LETTER for TCM Supply Corporation on April 25, 2012. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: TCM Supply Corporation
- Inspection Date: 2012-04-25
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: 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.

## Related Officers

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