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# CGMP Violations at China’s Dongying Tiandong
- URL: https://www.fdaweb.com/cgmp-violations-at-chinas-dongying-tiandong/
- Published: 2016-11-29T12:00:00.000Z
- Updated: 2026-09-14T21:51:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137440

A 10/12-16/15 FDA inspection at Dongying Tiandong Pharmaceutical Co., Shandong, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API), according to an 11/10 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm530369.htm?ref=fdaweb.com). Specific deviations included: 

- failing to adequately investigate and document out-of-specification results according to a procedure, and implement appropriate corrective actions;
- failing to ensure that test procedures are scientifically sound and appropriate to ensure that the APIs conform to established standards of quality and purity;
- failing to adequately monitor crude heparin suppliers; and
- failing to have the firm’s quality unit ensure that all critical deviations are investigated and resolved.

The company was told to respond with a list of steps it has taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completing the steps.