Warning Letter - Deficiencies in the Control of Raw and Starting Materials

The FDA has investigated the manufacturing practices of Shantou Kangjie Daily Chemical Industry Co, Ltd (China) and found significant violations of Current Good Manufacturing Practice (CGMP). The FDA concludes that the company's manufacturing processes do not meet the legal requirements, which means that the manufactured products are considered adulterated. The company was therefore placed on the 66-40 import warning list in the USA.

1. Key points of the violations

1.1. Lack of identity verification of raw materials (21 CFR 211.84(d)(1)).
The company did not perform systematic identity verification for incoming raw materials used in drug product manufacturing.
Of particular concern is that the ethanol used is not tested for methanol impurities, which poses a serious health risk.
The FDA requires the company to conduct a comprehensive evaluation of all suppliers and materials and to ensure the identity, strength, quality and purity of all components used.

1.2. Failure to have an adequate quality control (QU) unit (21 CFR 211.22(a))
The company has not established a functioning quality control (QU) unit responsible for monitoring the quality of all manufacturing processes.
As a result, the inspection and approval of materials, packaging and finished products is inadequate.
The FDA calls for a comprehensive evaluation of quality control systems and a remediation plan to strengthen the QU with clearly defined responsibilities and authorities.

2. Recommended actions

• Implement strict identity verification of all incoming raw materials.
• Qualification and monitoring of suppliers and materials to ensure product safety.
• Establish a functioning quality control unit with clear authority.
• Engage an external, qualified CGMP consultant to comprehensively review and improve manufacturing practices.
• Submit a detailed report to the FDA within 15 business days describing corrective actions taken and planned.

3. Consequences for failure to correct the violations

• Continued import bans on products from the affected manufacturing facility.
• Rejection of new applications for drug approval by the FDA.
• Possible further sanctions if appropriate corrections are not made.

The FDA expects prompt and complete remediation of all violations to ensure compliance with CGMP standards. Further details can be found directly in the Warning Letter der FDA.