FDA WARNING_LETTER - KPC Products Inc - December 20, 2017

On June 20, 2018, the FDA issued a Warning Letter to KPC Products, Inc. following an inspection of their dietary supplement manufacturing facility in Irvine, CA, on December 14, 19, and 20, 2017. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), causing their dietary supplement product, Tong Qiao Huo Xue Tang/Persica Ligusticum Combination, to be adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to establish component specifications:** KPC Products, Inc. did not establish identity specifications (21 CFR 111.70(b)(1)) or specifications for purity, strength, and composition (21 CFR 111.70(b)(2)) for components. Their proposed identity specification by color for Jia Wei Xiao Yao San was deemed insufficient. 2. **Failure to establish finished product specifications:** The company failed to establish identity, purity, strength, and composition specifications for finished dietary supplements (21 CFR 111.70(e)). Their proposed identity specification by color for Jia Wei Xiao Yao San was also deemed insufficient.

Additionally, the following products were found to be misbranded: Tong Qiao Huo Xue Tang, Chai