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# CGMP Violations at China’s Hubei Pharmaceutical Co.
- URL: https://www.fdaweb.com/cgmp-violations-at-chinas-hubei-pharmaceutical-co/
- Published: 2017-11-21T12:00:00.000Z
- Updated: 2026-09-14T23:02:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140185

A 7/31-8/4 FDA inspection at Hubei Danjiangkou Danao Pharmaceutical Co., Hubei Province, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API), according to an 11/6 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm585015.htm?ref=fdaweb.com). Specific deviations cited were: 

- failing to demonstrate that the firm’s manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes;
- failing of the quality unit to approve changes that potentially affect API quality; and
- failing to ensure that all test procedures are scientifically sound and appropriate to assure that the company’s API conform to established standards of quality and purity.

The firm’s response to the inspection observations was inadequate and did not provide sufficient evidence of corrective actions to bring its operations into compliance with CGMP, the letter says.

“Based upon the nature of the deviations we identified at your firm,” FDA says, “we strongly recommend engaging a consultant qualified to evaluate your operations and to assist your firm in meeting CGMP requirements.”

FDA placed the company on import alert on 11/1.