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

Source: https://www.keypedia.com/records/warning_letter/shantou-kangjie-daily-chemical-industry-co-ltd/4d6f4dd3-2954-43fd-9f95-6dc7123c6160

> FDA WARNING_LETTER for Shantou Kangjie Daily Chemical Industry Co., Ltd on January 23, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Shantou Kangjie Daily Chemical Industry Co., Ltd
- Inspection Date: 2025-01-23
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.keypedia.com/companies/shantou-kangjie-daily-chemical-industry-co-ltd/04d735e1-e509-4bed-bb40-529bbee7a7f5

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c