FDA WARNING_LETTER - Shantou Kangjie Daily Chemical Industry Co., Ltd - January 23, 2025

On January 28, 2025, the FDA issued a Warning Letter to Kangjie Company, a registered manufacturer of OTC drug products in China, following a review of records submitted on March 25, 2024, pursuant to section 704(a)(4) of the FD&C Act. The letter identifies significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR, parts 210 and 211), rendering their drug products adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Failure to conduct identity testing for drug product components (21 CFR 211.84(d)(1)):** The firm did not demonstrate testing of incoming raw materials, including ethanol used as an active ingredient, for identity. Specifically, they admitted not performing identity testing on each shipment/lot of drug ingredients and did not test incoming ethanol for methanol contamination, which has been linked to lethal poisoning incidents. 2. **Failure to establish an adequate quality control unit (21 CFR 211.22(a)):** The firm stated they do not have a Quality Unit (QU), indicating inadequate quality systems and a failure to oversee drug manufacturing operations effectively.

The FDA recommends engaging a qualified consultant (21 CFR 211.34) to evaluate operations, assist