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# CGMP Violations at 2 Xinxiang Facilities
- URL: https://www.fdaweb.com/cgmp-violations-at-2-xinxiang-facilities/
- Published: 2016-08-30T12:00:00.000Z
- Updated: 2026-09-14T21:28:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136646

FDA inspections at China’s Xinxiang Pharmaceutical Co. (9/14-16/15) and Xinxiang Tuoxin Biochemical Co. (9/15-18/15) found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (APIs), according to an 8/19 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm517942.htm?ref=fdaweb.com). Specific deviations cited in the letter include: 

- failing to properly maintain equipment used in the manufacture of APIs and to minimize the risk of contamination where open equipment is used; and
- failing to properly maintain, repair, and keep clean buildings used in the manufacture of APIs in a manner that prevents contamination where open equipment is used.

Both facilities were placed on 4/6 Import Alerts. The agency says it strongly recommends that the firm engage a third-party consultant qualified to evaluate its operations to assist it in meeting CGMP requirements. Xinxiang was told to respond with steps taken since the inspections to correct the deviations and prevent their recurrence, with a timetable for completion.