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# CGMP Violations at Cheng Fong Chemical
- URL: https://www.fdaweb.com/cgmp-violations-at-cheng-fong-chemical/
- Published: 2016-09-27T12:00:00.000Z
- Updated: 2026-09-14T21:35:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136918

A 4/18-4/22 FDA inspection at Cheng Fong Chemical Co., Taoyuan City, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API). A 9/15 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm521320.htm?ref=fdaweb.com) says the deviations included: 

- failing to have an adequate maintenance procedure to prevent contamination or carry-over of a material that would alter the quality of the API;
- failing to adequately conduct investigations and extend the investigations to other batches that may have been associated with the failure or deviation; and
- failing to properly maintain buildings used in the manufacture of API in a clean condition.

 The letter acknowledges the firm’s corrective actions, including cleaning and adding cold rooms to its pest control program. It lists five items to be submitted to FDA in its response to the inspection findings. Cheng Fong was told to respond with a list of actions taken since the inspection to correct the deviations and prevent their recurrence, along with a timetable for completion.