FDA 483 - Yicheng Chemical Corp. - July 21, 2017

Yicheng Chemical Corp. in Changzhou, China, was inspected by the FDA from July 17-21, 2017, and received eight observations. The inspection revealed significant deficiencies across its Active Pharmaceutical Ingredient (API) manufacturing operations, including a complete lack of a quality control unit, inadequate testing and release procedures, and no written procedures for critical processes like recall, calibration, production controls, or stability testing. These findings indicate a severe lack of fundamental quality systems and controls for API handling and distribution.