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# CGMP Violations at Qinhuangdao Zizhu
- URL: https://www.fdaweb.com/cgmp-violations-at-qinhuangdao-zizhu/
- Published: 2017-06-20T12:00:00.000Z
- Updated: 2026-09-14T22:30:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138977

An 11/28-12/1/16 FDA inspection at Qinhuangdao Zizhu Pharmaceutical Co., Beijing, China, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API) according to a just-released 4/24 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm563170.htm?ref=fdaweb.com). Specific deviations included: 

- failing to prevent unauthorized access or changes to data, and failing to provide adequate controls to prevent omission of data;
- failing to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards; and
- failing of the firm’s quality unit to exercise its responsibility to ensure that API manufactured at the facility comply with CGMP and meet established specifications for quality and purity.

FDA says the company’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures and recommends that it retain a qualified consultant to assist in remediation. The firm was told to provide **(1)** a comprehensive investigation into the extent of inaccuracies in data records and reporting; **(2)** a current risk assessment of the potential effects of the observed failures on the quality of its drugs; and **(3)** a management strategy for the company including details of its global corrective and preventive action plan.

FDA placed the company on import alert 3/8\. The firm was told to respond with any steps it has taken since the inspection to correct the violations and prevent their recurrence.