FDA Flags CGMP Violations at Shantou Kangjie Daily Chemical Industry Co., Ltd.

The U.S. FDA has identified significant CGMP violations at Shantou Kangjie Daily Chemical Industry Co., Ltd. (China), leading to its placement on the 66-40 import alert list in the U.S.

Key Violations

1. Failure to Verify Raw Material Identity (21 CFR 211.84(d)(1))
• No systematic identity checks on raw materials.
• Ethanol was not tested for methanol impurities, posing health risks.
• FDA mandates supplier evaluations and strict component testing.
2. Inadequate Quality Control (21 CFR 211.22(a))
• No functioning Quality Control (QU) unit for manufacturing oversight.
• Poor inspection of materials, packaging, and finished products.
• FDA requires a structured QU system with defined roles.

Required Actions

• Strict raw material verification and supplier qualification.
• Establish a competent Quality Control unit.
• Hire an external CGMP consultant for a manufacturing review.
• Submit a corrective action plan within 15 business days.

Consequences

• Continued U.S. import bans, FDA application rejections, and further regulatory actions if issues persist.

Refer to the FDA’s Warning Letter for details.

17-03-2025

• Pharma GMP
• Food GMP
• Clinical Research
• Medical Device
• Environmental Health and Safety
• Healthcare
• Nutrition